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 |
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Gingival Recession | Procedure: FTPGT Procedure: SCTG | Not Applicable |
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 : | 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 |
Arm | Intervention/treatment |
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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.
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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.
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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.
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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
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Italy | |
G. d'Annunzio University | |
Chieti, CH, Italy, 66100 |
Principal Investigator: | michele paolantonio | università G. D'annunzio Chieti-Pescara |
Tracking Information | |||||
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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 |
gingival recession [ Time Frame: 6 months ] distance from cementoenamel junction and gingival margin
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures ICMJE |
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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. |
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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. |
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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. |
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Condition ICMJE | Gingival Recession | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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IPD Sharing Statement ICMJE |
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Responsible Party | Michele Paolantonio, G. d'Annunzio University | ||||
Study Sponsor ICMJE | G. d'Annunzio University | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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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 |