The Relationship Between Root Coverage Procedures and Buccal Vestibular Depth

Effect of Different Recession Coverage Approaches on Sites With Shallow Vestibule Depth

In this comparative trial, 50 patients with shallow vestibules and Type 1/2 recessions will be treated with either a vertically coronally advanced flap + connective tissue graft or a free gingival graft. At baseline, 3rd-month, 6th-month, and 12th-month visits, the following parameters will be evaluated: buccal vestibular depth, keratinized tissue height, gingival thickness, recession depth, recession width, probing depth, and clinical attachment level. Keratinized tissue change, gingival thickness change, root coverage, clinical attachment gain, and complete root coverage will be calculated. The wound healing index, tissue appearance, patient expectations, aesthetics, and dentin hypersensitivity will be assessed at baseline and at the 6th week.

Study Overview

• Status: Completed
• Conditions: Gingival Recession; Shallow Vestibular Depth
• Intervention / Treatment: Procedure: Vertically coronally advanced flap combined with connective tissue graft.; Procedure: Free gingival graft

Detailed Description

Buccal vestibule depth was recorded using two different measurement methods. First, the distance between the cementoenamel junction and the deepest point of the vestibule sulcus was measured and recorded as VD1. Then, the distance between the gingival margin and the base of the vestibule sulcus was measured and recorded as VD2.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06100
    • Hacettepe University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• full-mouth plaque and bleeding scores <15%
• the presence of at least one recession type-1/2 recession and at least one recession with recession depth ≥ 2 mm
• the presence of an identifiable cemento-enamel junction

Exclusion Criteria:

• Vestibule depth > 6mm
• Smoking > 10 cigarettes per day
• Any contraindications for periodontal surgery
• Unstable endodontic conditions or presence of any restoration.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Free Gingival Graft	Procedure: Free gingival graft; A partial-thickness flap is elevated (using a blade #15c) with horizontal incisions at the cemento-enamel junction (CEJ) level of the adjacent teeth. Then, two vertical incisions extending to the apical are made from the two ends of the horizontal incision. The epithelium in the framed region is removed with a scalpel, and the underlying connective tissue is exposed. To achieve the best vascularization of the free gingival graft from the recipient site, bed preparation is completed with a split-thickness horizontal incision that joins the vertical incisions in the apical region. The free gingival graft is stabilized using interrupted sutures and a sling suture.; Other Names: epithelialized free gingival graft
Active Comparator: Vertically Coronally advanced flap combined with connective tissue graft	Procedure: Vertically coronally advanced flap combined with connective tissue graft.; The exposed root surfaces are planed with Gracey 1-2 curettes. An intrasulcular incision is made with a blade on the buccal aspects of the involved teeth. The incision is extended horizontally to the adjacent papilla. Then, slightly divergent vertical releasing incisions are carried 2 mm beyond the mucogingival junction. A full-thickness flap is raised with a periosteal elevator towards the mucogingival junction. After that, a partial-thickness dissection is carried out in the apical direction to release muscle tension and provide coronal advancement of the flap. The adjacent papillae are de-epithelialized. The connective tissue graft (CTG) is harvested from the lateral palate using the de-epithelialized gingival graft technique. After harvesting, the connective tissue graft is sutured to the recipient bed. Finally, the flap is positioned 2 mm over the cementoenamel junction and sutured with 6-0 polypropylene sutures. No periodontal dressing is applied.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vestibule depth 2	The distance between the free gingival margin and the most apical point of the vestibul.	Baseline
Vestibule depth 2	The distance between the free gingival margin and the most apical point of the vestibul.	3rd month
Vestibule depth 2	The distance between the free gingival margin and the most apical point of the vestibul.	6th month
Vestibule depth 2	The distance between the free gingival margin and the most apical point of the vestibul.	12th month.
Vestibule depth 1	The distance between the free semento-enamel junction and the most apical point of the vestibul.	Baseline
Vestibule depth 1	The distance between the free semento enamel junction and the most apical point of the vestibul.	3rd month
Vestibule depth 1	The distance between the free semento-enamel junction and the most apical point of the vestibul.	6th month
Vestibule depth 1	The distance between the free semento-enamel junction and the most apical point of the vestibul.	12th month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tissue appearance (TA)	Tissue appearance (TA) was evaluated by asking the patients to score the consistency, contour, color match, keloid formation degree and contiguity of their treated sites at T2. The scores were collected as points, shown in parentheses, by asking the consistency as firm (1p) or spongy (0p); contour as presence (2p) or absence (0p) of knife-edged and scalloped gingival margin; color match as excellent (3p), good (2p), adequate (1p) or unsatisfactory (0p); keloid formation degree as absent (1p) or present (0p); contiguity as the presence (-1p) or absence (0p) of each perceptible incision mark.	6th week
Dentine hypersensitivity (DH)	Dentine hypersensitivity (DH) was evaluated with air evaporative stimulus method at baseline and T2. After placement of finger(s) for preserving the nearby teeth, the recession sites were subjected to evaporative stimulus comprised of 1-second air blast from 1 to 3 mm distance by using the air spray at 40-65 psi pressure and 19±50C. After application, the patients were requested to give a score to their DH between 0 (=no pain) and 10 (=extreme pain).	6th week
Patient expectations (PE)	Patient expectations (PE) were evaluated by requesting from the patients to rate their treatment results at T2, as satisfactory or not, in terms of appearance, experience and obtained root coverage.	6th week
Aesthetics (A)	Aesthetics (A) was evaluated by the patient at T1 by rating its level as excellent, good, fair or poor.	6th week
Recession depth (RD)	Measured as the distance from the cementoenamel junction to the gingival margin	Baseline
Recession depth (RD)	Measured as the distance from the cementoenamel junction to the gingival margin	6th week
Recession depth (RD)	Measured as the distance from the cementoenamel junction to the gingival margin	6th month.
Recession depth (RD)	Measured as the distance from the cementoenamel junction to the gingival margin	12th month.
Probing depth (PD)	Measures as the distance from the apical of gingival sulcus to the gingival margin.	Baseline
Probing depth (PD)	Measures as the distance from the apical of gingival sulcus to the gingival margin.	6th week
Probing depth (PD)	Measures as the distance from the apical of gingival sulcus to the gingival margin.	6th month
Probing depth (PD)	Measures as the distance from the apical of gingival sulcus to the gingival margin.	12th month.
Clinical attachment level (CAL)	measured as the distance from th tip of the probe inserted into the sulcus to de cementoenamel junction.	Baseline.
Clinical attachment level (CAL)	measured as the distance from th tip of the probe inserted into the sulcus to de cementoenamel junction.	6th week
Clinical attachment level (CAL)	measured as the distance from th tip of the probe inserted into the sulcus to de cementoenamel junction.	6th month
Clinical attachment level (CAL)	measured as the distance from th tip of the probe inserted into the sulcus to de cementoenamel junction.	12th month.
Keratinized tissue height (KTH)	measured from the most apical point of the recession at the gingival margin to the mucogingival line.	Baseline.
Keratinized tissue height (KTH)	measured from the most apical point of the recession at the gingival margin to the mucogingival line.	6th week
Keratinized tissue height (KTH)	measured from the most apical point of the recession at the gingival margin to the mucogingival line.	6th month
Keratinized tissue height (KTH)	measured from the most apical point of the recession at the gingival margin to the mucogingival line.	12th month.
Gingival thickness (GT)	determined 1.5 mm apical to the gingival margin, measured with the caliper accurete to the nearest 0.1 mm.	Baseline.
Gingival thickness (GT)	determined 1.5 mm apical to the gingival margin, measured with the caliper accurete to the nearest 0.1 mm.	6th week.
Gingival thickness (GT)	determined 1.5 mm apical to the gingival margin, measured with the caliper accurete to the nearest 0.1 mm.	6th month.
Gingival thickness (GT)	determined 1.5 mm apical to the gingival margin, measured with the caliper accurete to the nearest 0.1 mm.	12th month.
Wound healing index (WHI)	Wound healing index (WHI) was recorded two-weeks after surgery. The wound surface was visually inspected and the soft tissue healing was defined as 'uneventful' (score 1), 'slightly disturbed' (score 2) or 'poor' (score 3) based on the presence and severity of the items including patient discomfort, erythema, edema, suppuration and flap dehiscence.	2nd week

Collaborators and Investigators

• Sponsor: Hacettepe University

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2021
• Primary Completion (Actual): January 3, 2023
• Study Completion (Actual): January 15, 2023

Study Registration Dates

• First Submitted: March 9, 2023
• First Submitted That Met QC Criteria: March 20, 2023
• First Posted (Actual): March 21, 2023

Study Record Updates

• Last Update Posted (Actual): March 23, 2023
• Last Update Submitted That Met QC Criteria: March 22, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Periodontal Atrophy; Gingival Recession
• Other Study ID Numbers: Buccal Vestibule Depth

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No