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The Relationship Between Root Coverage Procedures and Buccal Vestibular Depth

Primary Purpose

Shallow Vestibular Depth, Gingival Recession

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Vertically coronally advanced flap combined with connective tissue graft.
Free gingival graft
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shallow Vestibular Depth

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Hacettepe University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Vertically Coronally advanced flap combined with connective tissue graft

Free Gingival Graft

Arm Description

Outcomes

Primary Outcome Measures

Vestibule depth 2
The distance between the free gingival margin and the most apical point of the vestibul.
Vestibule depth 2
The distance between the free gingival margin and the most apical point of the vestibul.
Vestibule depth 2
The distance between the free gingival margin and the most apical point of the vestibul.
Vestibule depth 2
The distance between the free gingival margin and the most apical point of the vestibul.
Vestibule depth 1
The distance between the free semento-enamel junction and the most apical point of the vestibul.
Vestibule depth 1
The distance between the free semento enamel junction and the most apical point of the vestibul.
Vestibule depth 1
The distance between the free semento-enamel junction and the most apical point of the vestibul.
Vestibule depth 1
The distance between the free semento-enamel junction and the most apical point of the vestibul.

Secondary Outcome Measures

Recession depth (RD)
Measured as the distance from the cementoenamel junction to the gingival margin
Recession depth (RD)
Measured as the distance from the cementoenamel junction to the gingival margin
Recession depth (RD)
Measured as the distance from the cementoenamel junction to the gingival margin
Recession depth (RD)
Measured as the distance from the cementoenamel junction to the gingival margin
Probing depth (PD)
Measures as the distance from the apical of gingival sulcus to the gingival margin.
Probing depth (PD)
Measures as the distance from the apical of gingival sulcus to the gingival margin.
Probing depth (PD)
Measures as the distance from the apical of gingival sulcus to the gingival margin.
Probing depth (PD)
Measures as the distance from the apical of gingival sulcus to the gingival margin.
Clinical attachment level (CAL)
measured as the distance from th tip of the probe inserted into the sulcus to de cementoenamel junction.
Clinical attachment level (CAL)
measured as the distance from th tip of the probe inserted into the sulcus to de cementoenamel junction.
Clinical attachment level (CAL)
measured as the distance from th tip of the probe inserted into the sulcus to de cementoenamel junction.
Clinical attachment level (CAL)
measured as the distance from th tip of the probe inserted into the sulcus to de cementoenamel junction.
Keratinized tissue height (KTH)
measured from the most apical point of the recession at the gingival margin to the mucogingival line.
Keratinized tissue height (KTH)
measured from the most apical point of the recession at the gingival margin to the mucogingival line.
Keratinized tissue height (KTH)
measured from the most apical point of the recession at the gingival margin to the mucogingival line.
Keratinized tissue height (KTH)
measured from the most apical point of the recession at the gingival margin to the mucogingival line.
Gingival thickness (GT)
determined 1.5 mm apical to the gingival margin, measured with the caliper accurete to the nearest 0.1 mm.
Gingival thickness (GT)
determined 1.5 mm apical to the gingival margin, measured with the caliper accurete to the nearest 0.1 mm.
Gingival thickness (GT)
determined 1.5 mm apical to the gingival margin, measured with the caliper accurete to the nearest 0.1 mm.
Gingival thickness (GT)
determined 1.5 mm apical to the gingival margin, measured with the caliper accurete to the nearest 0.1 mm.
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.
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.
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).
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.
Aesthetics (A)
Aesthetics (A) was evaluated by the patient at T1 by rating its level as excellent, good, fair or poor.

Full Information

First Posted
March 9, 2023
Last Updated
March 22, 2023
Sponsor
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT05777811
Brief Title
The Relationship Between Root Coverage Procedures and Buccal Vestibular Depth
Official Title
Effect of Different Recession Coverage Approaches on Sites With Shallow Vestibule Depth
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
January 3, 2021 (Actual)
Primary Completion Date
January 3, 2023 (Actual)
Study Completion Date
January 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Masking Description
Patients were randomly assigned to either the Vertically Coronally Advanced Flap (n=25) group or the Free Gingival Graft (n=25) group by one of the authors, with an allocation ratio of 1:1, using a computer-generated program after the successful completion of Phase I periodontal treatment. One calibrated author applied the surgical technique and recorded all clinical variables. The surgeon opened the labeled envelope containing the intervention name.
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vertically Coronally advanced flap combined with connective tissue graft
Arm Type
Active Comparator
Arm Title
Free Gingival Graft
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Vertically coronally advanced flap combined with connective tissue graft.
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Free gingival graft
Other Intervention Name(s)
epithelialized free gingival graft
Intervention Description
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.
Primary Outcome Measure Information:
Title
Vestibule depth 2
Description
The distance between the free gingival margin and the most apical point of the vestibul.
Time Frame
Baseline
Title
Vestibule depth 2
Description
The distance between the free gingival margin and the most apical point of the vestibul.
Time Frame
3rd month
Title
Vestibule depth 2
Description
The distance between the free gingival margin and the most apical point of the vestibul.
Time Frame
6th month
Title
Vestibule depth 2
Description
The distance between the free gingival margin and the most apical point of the vestibul.
Time Frame
12th month.
Title
Vestibule depth 1
Description
The distance between the free semento-enamel junction and the most apical point of the vestibul.
Time Frame
Baseline
Title
Vestibule depth 1
Description
The distance between the free semento enamel junction and the most apical point of the vestibul.
Time Frame
3rd month
Title
Vestibule depth 1
Description
The distance between the free semento-enamel junction and the most apical point of the vestibul.
Time Frame
6th month
Title
Vestibule depth 1
Description
The distance between the free semento-enamel junction and the most apical point of the vestibul.
Time Frame
12th month
Secondary Outcome Measure Information:
Title
Recession depth (RD)
Description
Measured as the distance from the cementoenamel junction to the gingival margin
Time Frame
Baseline
Title
Recession depth (RD)
Description
Measured as the distance from the cementoenamel junction to the gingival margin
Time Frame
6th week
Title
Recession depth (RD)
Description
Measured as the distance from the cementoenamel junction to the gingival margin
Time Frame
6th month.
Title
Recession depth (RD)
Description
Measured as the distance from the cementoenamel junction to the gingival margin
Time Frame
12th month.
Title
Probing depth (PD)
Description
Measures as the distance from the apical of gingival sulcus to the gingival margin.
Time Frame
Baseline
Title
Probing depth (PD)
Description
Measures as the distance from the apical of gingival sulcus to the gingival margin.
Time Frame
6th week
Title
Probing depth (PD)
Description
Measures as the distance from the apical of gingival sulcus to the gingival margin.
Time Frame
6th month
Title
Probing depth (PD)
Description
Measures as the distance from the apical of gingival sulcus to the gingival margin.
Time Frame
12th month.
Title
Clinical attachment level (CAL)
Description
measured as the distance from th tip of the probe inserted into the sulcus to de cementoenamel junction.
Time Frame
Baseline.
Title
Clinical attachment level (CAL)
Description
measured as the distance from th tip of the probe inserted into the sulcus to de cementoenamel junction.
Time Frame
6th week
Title
Clinical attachment level (CAL)
Description
measured as the distance from th tip of the probe inserted into the sulcus to de cementoenamel junction.
Time Frame
6th month
Title
Clinical attachment level (CAL)
Description
measured as the distance from th tip of the probe inserted into the sulcus to de cementoenamel junction.
Time Frame
12th month.
Title
Keratinized tissue height (KTH)
Description
measured from the most apical point of the recession at the gingival margin to the mucogingival line.
Time Frame
Baseline.
Title
Keratinized tissue height (KTH)
Description
measured from the most apical point of the recession at the gingival margin to the mucogingival line.
Time Frame
6th week
Title
Keratinized tissue height (KTH)
Description
measured from the most apical point of the recession at the gingival margin to the mucogingival line.
Time Frame
6th month
Title
Keratinized tissue height (KTH)
Description
measured from the most apical point of the recession at the gingival margin to the mucogingival line.
Time Frame
12th month.
Title
Gingival thickness (GT)
Description
determined 1.5 mm apical to the gingival margin, measured with the caliper accurete to the nearest 0.1 mm.
Time Frame
Baseline.
Title
Gingival thickness (GT)
Description
determined 1.5 mm apical to the gingival margin, measured with the caliper accurete to the nearest 0.1 mm.
Time Frame
6th week.
Title
Gingival thickness (GT)
Description
determined 1.5 mm apical to the gingival margin, measured with the caliper accurete to the nearest 0.1 mm.
Time Frame
6th month.
Title
Gingival thickness (GT)
Description
determined 1.5 mm apical to the gingival margin, measured with the caliper accurete to the nearest 0.1 mm.
Time Frame
12th month.
Title
Wound healing index (WHI)
Description
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.
Time Frame
2nd week
Title
Tissue appearance (TA)
Description
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.
Time Frame
6th week
Title
Dentine hypersensitivity (DH)
Description
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).
Time Frame
6th week
Title
Patient expectations (PE)
Description
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.
Time Frame
6th week
Title
Aesthetics (A)
Description
Aesthetics (A) was evaluated by the patient at T1 by rating its level as excellent, good, fair or poor.
Time Frame
6th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Hacettepe University
City
Ankara
ZIP/Postal Code
06100
Country
Turkey

12. IPD Sharing Statement

Learn more about this trial

The Relationship Between Root Coverage Procedures and Buccal Vestibular Depth

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