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出境医 / 临床实验 / Complete Root Coverage of Gingival Recession: the Full Thickness Palatal Graft Versus the Bilaminar Technique

Complete Root Coverage of Gingival Recession: the Full Thickness Palatal Graft Versus the Bilaminar Technique

Study Description
Brief Summary:

In this randomized controlled clinical trial we compare the clinical outcome of Full thickness palatal graft technique (FTPGT) to Langer & Langer modified technique in the treatment of Miller's class II recessions.

Forty patients, presenting at least one Miller's class II gingival recession, were treated with bilaminar procedures . 20 participants received FTPGT approach (test group) and 20 patients underwent Langer & Langer modified technique (control group). A complete clinical examination was performed at base-line and 6 months after treatment. Gingival recession (GR) Clinical attachment level (CAL) pocket depth (PD) keratinized tissue height (KT) thickness of keratinized tissue (TK) were assessed during follow-up.


Condition or disease Intervention/treatment Phase
Gingival Recession Procedure: FTPGT Procedure: SCTG Not Applicable

Detailed Description:

This study was a prospective, randomized and controlled clinical trial designed to compare two modalities of treatment of Miller's class II recession: FTPG versus Langer &Langer modified technique. From each patient study was included one Miller's class II recession, in patient with multiple Miller's class II recession was included the deepest one. Clinical parameters were evaluated at base-line and after 6 months.

40 patients seeking treatment at the Unit of Periodontology of the University of Chieti, Pescara, Italy, and affected by Miller's class II recession were selected for the study. The participants volunteered for the study after they received verbal and written information and signed a consent form approved by the Ethical Committee of the "G. D'Annunzio" University Medical Faculty. The study protocol was in accordance with the Declaration of Helsinki of 1975, then revised in Tokyo in 2004.

All 40 patient underwent a professional supra-gingival scaling by ultrasonic instruments. To each patient were given motivational oral home care instructions in order to acquire correct and pressure-less brushing technique and a-traumatic use of dental floss and/or inter-dental brush. In addition it was suggested electric toothbrush use with controlled pressure with extra-soft head and instructions about it were conferred. Only The achievement of supra-gingival plaque control through a-traumatic oral hygiene procedures permit the access of the surgical step.

A sample size of 40 patient (20 for group) was calculated to detect clinical statistical difference of 1 mm in root coverage with α= 0.005 and to prevent a reduction of statistical power due to hypothetical patient's drop out.

Student's t-test for unpaired samples and analysis were used to harmonize the different age and gender in each group.

Custom made computer-generated table provides the randomly allocation of experimental unit in the two groups.

To conceal allocation, opaque envelopes containing the treatment of the specific subject were assigned to the specific patient and were opened during surgery, immediately before making clinical measurements.

All measurements were performed by a single experienced operator. To ensure intra-examiner reproducibility, calibration sessions were performed until a standard deviation of the difference of three consecutive measurements <0.5mm for the GR(primary outcome) has reached.

The post-surgical care is founded for all patients on 2 g/day amoxicillin plus clavulanic acid for 6 days, oral ketoprofen for pain-control if needed . Two weeks after surgery suture were removed. Plaque control of grafted area was performed for 3 weeks after surgery through a double rinse in a day with 0.12% chlorhexidine digluconate solution. Than patients were instructed again in mechanical tooth cleaning of the grafted area using an ultra-soft manual toothbrush for 1 month.

Patients were recalled once a week for the first 4weeks after the surgery where they underwent gentle supra-gingival professional tooth cleaning and oral hygiene motivation reinforcement.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Forty patients, presenting at least one Miller's class II gingival recession, were treated with bilaminar procedures . 20 participants received FTPGT approach (test group) and 20 patients underwent Langer & Langer modified technique (control group). A complete clinical examination was performed at base-line and 6 months
Masking: Single (Investigator)
Masking Description:

Custom made computer-generated table provides the randomly allocation of experimental unit in the two groups.

To conceal allocation, opaque envelopes containing the treatment of the specific subject were assigned to the specific patient and were opened during surgery, immediately before making clinical measurements.

Primary Purpose: Treatment
Official Title: Clinical Comparison of Two Surgical Techniques in Obtaining Complete Root Coverage: a Randomized and Controlled Study
Study Start Date : January 2008
Actual Primary Completion Date : April 2009
Actual Study Completion Date : September 2009
Arms and Interventions
Arm Intervention/treatment
Experimental: FTPG treated patient
the recipient bed preparation was made according to langer&langer modified technique. Intrasulcular incision was performed from at least one tooth mesial and at least one tooth distal to the teeth with gingival recession. No vertical incisions were made to provide better blood supply. A partial thickness flap was created. In Test group, the harvest of palatal graft was performed using FTPG technique. The palatal graft was adapted to recipient site in order to put on exposed root the full thickness area, that having been custom designed it will fill perfectly the box of the recession. Interrupted suture was completed.
Procedure: FTPGT
A primary full thickness incision was given at 90 degrees to the long axis of the tooth and directly to the bone, A secondary split thickness incision was performed at 90 degrees to the long axis of the tooth but not directly to the bone, to circumscribe an area that has the same size of the gingival recession you want to cover .in a part of the first incision in order to preserve the area of tissue between them. A partial thickness flap is raised. Then two vertical incisions to the bone on the mesial and distal ends of the graft and one horizontal medial incision is made (under the partial thickness flap), to release it from the surrounding tissue incision were made, inserting the blade as much as possible parallel to the long axis of the teeth, the connective tissue was elevated from the underlying bone with a periosteal elevator.

Active Comparator: Sub-epithelial connective tissue graft (SCTG) treated patient
the recipient bed preparation was made according to langer&langer modified technique. Intrasulcular incision was performed from at least one tooth mesial and at least one tooth distal to the teeth with gingival recession. No vertical incisions were made to provide better blood supply. A partial thickness flap was created. To ensure an effective randomization only at this stage the patients were assigned to the test and to the control group.In control group trap door technique was used to obtain connective palatal graft. SCTG was adapted to recipient site in way that the first mm upon cementoenamel junction (CEJ) was covered , the flap is stabilized with interrupted sutures. The palatal graft was adapted to recipient site in order to put on exposed root the full thickness area, that having been custom designed it will fill perfectly the box of the recession. Interrupted suture was completed.
Procedure: SCTG
A primary full thickness incision was given at 90 degrees to the long axis of the tooth and directly to the bone, a falp was elevated, three inner incision eas performed and the connective tissue graft was harvested

Outcome Measures
Primary Outcome Measures :
  1. gingival recession [ Time Frame: 6 months ]
    distance from cementoenamel junction and gingival margin


Secondary Outcome Measures :
  1. Clinical attachment level (CAL) [ Time Frame: 6 months ]
    distance between cementoenamel junction(CEJ) and depth of the pocket

  2. pocket depth (PD) [ Time Frame: 6 months ]
    distance between gingival margin and depth of the pocket

  3. thickness of keratinized tissue (TK) [ Time Frame: 6 months ]
    the distance between the hard root surface and the gingival surface

  4. keratinized tissue height (KT) [ Time Frame: 6 months ]
    the distance between gingival margin and Mucogingival Junction


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • systemic factors (no systemic diseases; no coagulation disorders; no medications affecting periodontal status in the previous 6 months; no pregnancy or lactation
  • behavioral factor (not smokers)
  • dental and periodontal general factors [a full-mouth plaque score (FMPS)and a full-mouth bleeding score (FMBS)25 lower than 20% achieved through an atraumatic oral home care, at the time of surgery
  • no periodontal surgery on the experimental sites
  • no inadequate endodontic treatment nor tooth mobility at the site of surgery
  • dental and periodontal experimental site factors (no presence of cervical carious lesions

Exclusion Criteria:

  • systemic diseases
  • coagulation disorders
  • medications affecting periodontal status in the previous 6 months
  • pregnancy or lactation
  • Smokers
Contacts and Locations

Locations
Layout table for location information
Italy
G. d'Annunzio University
Chieti, CH, Italy, 66100
Sponsors and Collaborators
G. d'Annunzio University
Investigators
Layout table for investigator information
Principal Investigator: michele paolantonio università G. D'annunzio Chieti-Pescara
Tracking Information
First Submitted Date  ICMJE July 17, 2019
First Posted Date  ICMJE July 22, 2019
Last Update Posted Date July 22, 2019
Study Start Date  ICMJE January 2008
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 19, 2019)
gingival recession [ Time Frame: 6 months ]
distance from cementoenamel junction and gingival margin
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 19, 2019)
  • Clinical attachment level (CAL) [ Time Frame: 6 months ]
    distance between cementoenamel junction(CEJ) and depth of the pocket
  • pocket depth (PD) [ Time Frame: 6 months ]
    distance between gingival margin and depth of the pocket
  • thickness of keratinized tissue (TK) [ Time Frame: 6 months ]
    the distance between the hard root surface and the gingival surface
  • keratinized tissue height (KT) [ Time Frame: 6 months ]
    the distance between gingival margin and Mucogingival Junction
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Complete Root Coverage of Gingival Recession: the Full Thickness Palatal Graft Versus the Bilaminar Technique
Official Title  ICMJE Clinical Comparison of Two Surgical Techniques in Obtaining Complete Root Coverage: a Randomized and Controlled Study
Brief Summary

In this randomized controlled clinical trial we compare the clinical outcome of Full thickness palatal graft technique (FTPGT) to Langer & Langer modified technique in the treatment of Miller's class II recessions.

Forty patients, presenting at least one Miller's class II gingival recession, were treated with bilaminar procedures . 20 participants received FTPGT approach (test group) and 20 patients underwent Langer & Langer modified technique (control group). A complete clinical examination was performed at base-line and 6 months after treatment. Gingival recession (GR) Clinical attachment level (CAL) pocket depth (PD) keratinized tissue height (KT) thickness of keratinized tissue (TK) were assessed during follow-up.

Detailed Description

This study was a prospective, randomized and controlled clinical trial designed to compare two modalities of treatment of Miller's class II recession: FTPG versus Langer &Langer modified technique. From each patient study was included one Miller's class II recession, in patient with multiple Miller's class II recession was included the deepest one. Clinical parameters were evaluated at base-line and after 6 months.

40 patients seeking treatment at the Unit of Periodontology of the University of Chieti, Pescara, Italy, and affected by Miller's class II recession were selected for the study. The participants volunteered for the study after they received verbal and written information and signed a consent form approved by the Ethical Committee of the "G. D'Annunzio" University Medical Faculty. The study protocol was in accordance with the Declaration of Helsinki of 1975, then revised in Tokyo in 2004.

All 40 patient underwent a professional supra-gingival scaling by ultrasonic instruments. To each patient were given motivational oral home care instructions in order to acquire correct and pressure-less brushing technique and a-traumatic use of dental floss and/or inter-dental brush. In addition it was suggested electric toothbrush use with controlled pressure with extra-soft head and instructions about it were conferred. Only The achievement of supra-gingival plaque control through a-traumatic oral hygiene procedures permit the access of the surgical step.

A sample size of 40 patient (20 for group) was calculated to detect clinical statistical difference of 1 mm in root coverage with α= 0.005 and to prevent a reduction of statistical power due to hypothetical patient's drop out.

Student's t-test for unpaired samples and analysis were used to harmonize the different age and gender in each group.

Custom made computer-generated table provides the randomly allocation of experimental unit in the two groups.

To conceal allocation, opaque envelopes containing the treatment of the specific subject were assigned to the specific patient and were opened during surgery, immediately before making clinical measurements.

All measurements were performed by a single experienced operator. To ensure intra-examiner reproducibility, calibration sessions were performed until a standard deviation of the difference of three consecutive measurements <0.5mm for the GR(primary outcome) has reached.

The post-surgical care is founded for all patients on 2 g/day amoxicillin plus clavulanic acid for 6 days, oral ketoprofen for pain-control if needed . Two weeks after surgery suture were removed. Plaque control of grafted area was performed for 3 weeks after surgery through a double rinse in a day with 0.12% chlorhexidine digluconate solution. Than patients were instructed again in mechanical tooth cleaning of the grafted area using an ultra-soft manual toothbrush for 1 month.

Patients were recalled once a week for the first 4weeks after the surgery where they underwent gentle supra-gingival professional tooth cleaning and oral hygiene motivation reinforcement.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Forty patients, presenting at least one Miller's class II gingival recession, were treated with bilaminar procedures . 20 participants received FTPGT approach (test group) and 20 patients underwent Langer & Langer modified technique (control group). A complete clinical examination was performed at base-line and 6 months
Masking: Single (Investigator)
Masking Description:

Custom made computer-generated table provides the randomly allocation of experimental unit in the two groups.

To conceal allocation, opaque envelopes containing the treatment of the specific subject were assigned to the specific patient and were opened during surgery, immediately before making clinical measurements.

Primary Purpose: Treatment
Condition  ICMJE Gingival Recession
Intervention  ICMJE
  • Procedure: FTPGT
    A primary full thickness incision was given at 90 degrees to the long axis of the tooth and directly to the bone, A secondary split thickness incision was performed at 90 degrees to the long axis of the tooth but not directly to the bone, to circumscribe an area that has the same size of the gingival recession you want to cover .in a part of the first incision in order to preserve the area of tissue between them. A partial thickness flap is raised. Then two vertical incisions to the bone on the mesial and distal ends of the graft and one horizontal medial incision is made (under the partial thickness flap), to release it from the surrounding tissue incision were made, inserting the blade as much as possible parallel to the long axis of the teeth, the connective tissue was elevated from the underlying bone with a periosteal elevator.
  • Procedure: SCTG
    A primary full thickness incision was given at 90 degrees to the long axis of the tooth and directly to the bone, a falp was elevated, three inner incision eas performed and the connective tissue graft was harvested
Study Arms  ICMJE
  • Experimental: FTPG treated patient
    the recipient bed preparation was made according to langer&langer modified technique. Intrasulcular incision was performed from at least one tooth mesial and at least one tooth distal to the teeth with gingival recession. No vertical incisions were made to provide better blood supply. A partial thickness flap was created. In Test group, the harvest of palatal graft was performed using FTPG technique. The palatal graft was adapted to recipient site in order to put on exposed root the full thickness area, that having been custom designed it will fill perfectly the box of the recession. Interrupted suture was completed.
    Intervention: Procedure: FTPGT
  • Active Comparator: Sub-epithelial connective tissue graft (SCTG) treated patient
    the recipient bed preparation was made according to langer&langer modified technique. Intrasulcular incision was performed from at least one tooth mesial and at least one tooth distal to the teeth with gingival recession. No vertical incisions were made to provide better blood supply. A partial thickness flap was created. To ensure an effective randomization only at this stage the patients were assigned to the test and to the control group.In control group trap door technique was used to obtain connective palatal graft. SCTG was adapted to recipient site in way that the first mm upon cementoenamel junction (CEJ) was covered , the flap is stabilized with interrupted sutures. The palatal graft was adapted to recipient site in order to put on exposed root the full thickness area, that having been custom designed it will fill perfectly the box of the recession. Interrupted suture was completed.
    Intervention: Procedure: SCTG
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 19, 2019)
40
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2009
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • systemic factors (no systemic diseases; no coagulation disorders; no medications affecting periodontal status in the previous 6 months; no pregnancy or lactation
  • behavioral factor (not smokers)
  • dental and periodontal general factors [a full-mouth plaque score (FMPS)and a full-mouth bleeding score (FMBS)25 lower than 20% achieved through an atraumatic oral home care, at the time of surgery
  • no periodontal surgery on the experimental sites
  • no inadequate endodontic treatment nor tooth mobility at the site of surgery
  • dental and periodontal experimental site factors (no presence of cervical carious lesions

Exclusion Criteria:

  • systemic diseases
  • coagulation disorders
  • medications affecting periodontal status in the previous 6 months
  • pregnancy or lactation
  • Smokers
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04028037
Other Study ID Numbers  ICMJE uchieti2
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Michele Paolantonio, G. d'Annunzio University
Study Sponsor  ICMJE G. d'Annunzio University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: michele paolantonio università G. D'annunzio Chieti-Pescara
PRS Account G. d'Annunzio University
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP