Three-dimensional Changes in Free Gingival Grafts Around Dental Implants

Evaluation of the Three-dimensional Changes in Free Gingival Grafts Around Dental Implants

The purpose of this study is to evaluate the stability of the free gingival graft dimensions around dental implants and to compare three-dimensional changes according to smoking status. Its primary goal is to provide an answer to:

Is this grafting procedure stable around dental implants? Are there any differences in tissue stability between smoker and non-smoker patients?

Our study consists of 2 groups:

The first group includes smoker patients who need free gingival grafts around their dental implants (n=16).

The second group includes non-smoker patients who need free gingival grafts around their dental implants (n=16).

Clinical measurements will be recorded at the baseline, 1st month, 3rd month, and 6th month of the study. An intraoral digital scanner will be used to measure the dimension changes of the graft at the baseline, after the surgery, 1st month, 3rd month, and 6th month of the study. Wound healing will be evaluated on postoperative days 10, 1 month, 3 months, and 6 months. Visual Analog Scale will be used to measure postoperative pain, and the number of painkillers taken will be recorded.

Study Overview

• Status: Recruiting
• Conditions: Insufficient Keratinized Gingiva
• Intervention / Treatment: Procedure: Free gingival graft

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ayse E Selman; Phone Number: +905366393184; Email: aselman@biruni.edu.tr

Study Locations

• Turkey
  • Istanbul, Turkey
    • Recruiting
    • Biruni University
    • Contact: Ayşe Ege SELMAN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Periodontal and peri-implant tissue health
• Good oral hygiene (plaque accumulation <20%)
• Either around the functioning implant or in patients scheduled for second-stage surgery following implant surgery <2 mm keratinized gingiva on the vestibular side of the implant
• No systemic disease and medication use that may affect soft tissue healing.
• Volunteering to participate in the study

Exclusion Criteria:

• Systemic disease that is a contraindication to the surgical procedure,
• Uncontrolled diabetes (HbA1c > 7),
• Being pregnant or breastfeeding,
• Autoimmune and/or inflammatory diseases of the oral cavity,
• Active periodontal disease,
• Incorrectly positioned implants

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: smoker	Procedure: Free gingival graft; After adequate local anesthesia is achieved, a horizontal incision will be placed at mucogingival junction level to prepare the recipient bed. A split-thickness flap will be raised without disturbing the periosteum. A free gingival graft will be obtained from the palate. The graft will be shaped and sutured to the recipient surface.
Experimental: non-smoker	Procedure: Free gingival graft; After adequate local anesthesia is achieved, a horizontal incision will be placed at mucogingival junction level to prepare the recipient bed. A split-thickness flap will be raised without disturbing the periosteum. A free gingival graft will be obtained from the palate. The graft will be shaped and sutured to the recipient surface.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The three-dimensional changes of free gingival graft	An intraoral digital scanner will be used to assess the graft's dimensions alterations.	Baseline
The three-dimensional changes of free gingival graft.	An intraoral digital scanner will be used to assess the graft's dimensions alterations.	1st month
The three-dimensional changes of free gingival graft	An intraoral digital scanner will be used to assess the graft's dimensions alterations.	3rd month
The three-dimensional changes of free gingival graft	An intraoral digital scanner will be used to assess the graft's dimensions alterations.	6th month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Keratinized mucosa width	The apical-coronal distance from the mucosal margin to the mucogingival junction (MGJ) Measurements will be made at three points on implants (mesiobuccal, midbuccal, distobuccal) using a periodontal probe.	Baseline (prior to therapy)
Probing depth	Probing pocket depth: The distance from the base of the pocket to the mucosal margin. Measurements will be made at six points on all teeth/ implants (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, and distolingual) using a periodontal probe.	1st month
Keratinized mucosa width	The apical-coronal distance from the mucosal margin to the mucogingival junction (MGJ) Measurements will be made at three points on implants (mesiobuccal, midbuccal, distobuccal) using a periodontal probe.	1st month
Keratinized mucosa width	The apical-coronal distance from the mucosal margin to the mucogingival junction (MGJ) Measurements will be made at three points on implants (mesiobuccal, midbuccal, distobuccal) using a periodontal probe.	3rd month
Keratinized mucosa width	The apical-coronal distance from the mucosal margin to the mucogingival junction (MGJ) Measurements will be made at three points on implants (mesiobuccal, midbuccal, distobuccal) using a periodontal probe.	6th month
Probing depth	Probing pocket depth: The distance from the base of the pocket to the mucosal margin. Measurements will be made at six points on all teeth/ implants (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, and distolingual) using a periodontal probe.	Baseline
Probing depth	Probing pocket depth: The distance from the base of the pocket to the mucosal margin. Measurements will be made at six points on all teeth/ implants (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, and distolingual) using a periodontal probe.	3rd month
Probing depth	Probing pocket depth: The distance from the base of the pocket to the mucosal margin. Measurements will be made at six points on all teeth/ implants (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, and distolingual) using a periodontal probe.	6th month
Wound healing	Presence of infection (yes/no), soft tissue dehiscence (yes/no), and graft failure (yes/no) will be recorded.	10th day
Wound healing	Presence of infection (yes/no), soft tissue dehiscence (yes/no), and graft failure (yes/no) will be recorded.	1st month
Wound healing	Presence of infection (yes/no), soft tissue dehiscence (yes/no), and graft failure (yes/no) will be recorded.	3rd month
Wound healing	Presence of infection (yes/no), soft tissue dehiscence (yes/no), and graft failure (yes/no) will be recorded.	6th month
Patient reported outcomes	After the surgical procedure, patients will be asked to complete a form consisting of 4 items: (1) assessment of the intensity of postoperative pain/discomfort (by Visual Analog Scale), (2) duration of pain (in days), (3) number of analgesic tablets taken, and (4) willingness to undergo the same surgery again (yes/no).	10th day
Plaque index	0: Absence of microbial plaque Thin plaque layer at the mucosal margin, only detectable by scraping with a probe Moderate layer of plaque in the along the mucosal margin; interdental spaces free, but plaque is visible to naked eye Abundant plaque along with the mucosal margin; interdental places filled with plaque	Baseline
Plaque index	0: Absence of microbial plaque Thin plaque layer at the mucosal margin, only detectable by scraping with a probe Moderate layer of plaque in the along the mucosal margin; interdental spaces free, but plaque is visible to naked eye Abundant plaque along with the mucosal margin; interdental places filled with plaque	1st month
Plaque index	0: Absence of microbial plaque Thin plaque layer at the mucosal margin, only detectable by scraping with a probe Moderate layer of plaque in the along the mucosal margin; interdental spaces free, but plaque is visible to naked eye Abundant plaque along with the mucosal margin; interdental places filled with plaque	3rd month
Plaque index	0: Absence of microbial plaque Thin plaque layer at the mucosal margin, only detectable by scraping with a probe Moderate layer of plaque in the along the mucosal margin; interdental spaces free, but plaque is visible to naked eye Abundant plaque along with the mucosal margin; interdental places filled with plaque	6th month
Gingival Index	0: normal gingiva mild inflammation - slight change in color and slight edema but no bleeding on probing moderate inflammation - redness, edema and glazing, bleeding on probing severe inflammation - marked redness and edema, ulceration with tendency to spontaneous bleeding	Baseline (prior to therapy)
Gingival Index	0: normal gingiva mild inflammation - slight change in color and slight edema but no bleeding on probing moderate inflammation - redness, edema and glazing, bleeding on probing severe inflammation - marked redness and edema, ulceration with tendency to spontaneous bleeding	1st month
Gingival Index	0: normal gingiva mild inflammation - slight change in color and slight edema but no bleeding on probing moderate inflammation - redness, edema and glazing, bleeding on probing severe inflammation - marked redness and edema, ulceration with tendency to spontaneous bleeding	3rd month
Gingival Index	0: normal gingiva mild inflammation - slight change in color and slight edema but no bleeding on probing moderate inflammation - redness, edema and glazing, bleeding on probing severe inflammation - marked redness and edema, ulceration with tendency to spontaneous bleeding	6th month
Bleeding on probing	Bleeding on probing A bleeding-on-probing percentage score assessed as the proportion of bleeding sites (dichotomous yes/no evaluation) when stimulated by a standardized manual probe with a controlled (~25 g) force to the bottom of the sulcus/pocket at six sites (mesiobuccal, buccal, distobuccal, mesiolingual, lingual, distolingual) on all present teeth/ implants.	Baseline
Bleeding on probing	Bleeding on probing A bleeding-on-probing percentage score assessed as the proportion of bleeding sites (dichotomous yes/no evaluation) when stimulated by a standardized manual probe with a controlled (~25 g) force to the bottom of the sulcus/pocket at six sites (mesiobuccal, buccal, distobuccal, mesiolingual, lingual, distolingual) on all present teeth/ implants.	1st month
Bleeding on probing	Bleeding on probing A bleeding-on-probing percentage score assessed as the proportion of bleeding sites (dichotomous yes/no evaluation) when stimulated by a standardized manual probe with a controlled (~25 g) force to the bottom of the sulcus/pocket at six sites (mesiobuccal, buccal, distobuccal, mesiolingual, lingual, distolingual) on all present teeth/ implants.	3rd month
Bleeding on probing	Bleeding on probing A bleeding-on-probing percentage score assessed as the proportion of bleeding sites (dichotomous yes/no evaluation) when stimulated by a standardized manual probe with a controlled (~25 g) force to the bottom of the sulcus/pocket at six sites (mesiobuccal, buccal, distobuccal, mesiolingual, lingual, distolingual) on all present teeth/ implants.	6th month

Collaborators and Investigators

• Sponsor: Biruni University

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2024
• Primary Completion (Estimated): July 10, 2025
• Study Completion (Estimated): July 10, 2025

Study Registration Dates

• First Submitted: May 1, 2024
• First Submitted That Met QC Criteria: May 1, 2024
• First Posted (Actual): May 3, 2024

Study Record Updates

• Last Update Posted (Estimated): November 27, 2024
• Last Update Submitted That Met QC Criteria: November 25, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: free gingival graft dimention

Drug and device information, study documents

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