search
Back to results

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

Primary Purpose

Gingival Recession

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
FTPGT
SCTG
Sponsored by
G. d'Annunzio University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival Recession

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • G. d'Annunzio University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

FTPG treated patient

Sub-epithelial connective tissue graft (SCTG) treated patient

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

gingival recession
distance from cementoenamel junction and gingival margin

Secondary Outcome Measures

Clinical attachment level (CAL)
distance between cementoenamel junction(CEJ) and depth of the pocket
pocket depth (PD)
distance between gingival margin and depth of the pocket
thickness of keratinized tissue (TK)
the distance between the hard root surface and the gingival surface
keratinized tissue height (KT)
the distance between gingival margin and Mucogingival Junction

Full Information

First Posted
July 17, 2019
Last Updated
July 19, 2019
Sponsor
G. d'Annunzio University
search

1. Study Identification

Unique Protocol Identification Number
NCT04028037
Brief Title
Complete Root Coverage of Gingival Recession: the Full Thickness Palatal Graft Versus the Bilaminar Technique
Official Title
Clinical Comparison of Two Surgical Techniques in Obtaining Complete Root Coverage: a Randomized and Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
G. d'Annunzio University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
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.
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FTPG treated patient
Arm Type
Experimental
Arm Description
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.
Arm Title
Sub-epithelial connective tissue graft (SCTG) treated patient
Arm Type
Active Comparator
Arm Description
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 Type
Procedure
Intervention Name(s)
FTPGT
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
SCTG
Intervention Description
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
Primary Outcome Measure Information:
Title
gingival recession
Description
distance from cementoenamel junction and gingival margin
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Clinical attachment level (CAL)
Description
distance between cementoenamel junction(CEJ) and depth of the pocket
Time Frame
6 months
Title
pocket depth (PD)
Description
distance between gingival margin and depth of the pocket
Time Frame
6 months
Title
thickness of keratinized tissue (TK)
Description
the distance between the hard root surface and the gingival surface
Time Frame
6 months
Title
keratinized tissue height (KT)
Description
the distance between gingival margin and Mucogingival Junction
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
michele paolantonio
Organizational Affiliation
università G. D'annunzio Chieti-Pescara
Official's Role
Principal Investigator
Facility Information:
Facility Name
G. d'Annunzio University
City
Chieti
State/Province
CH
ZIP/Postal Code
66100
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs