Impact of Keratinized Mucosa Augmentation on Treatment Outcomes of Peri-implant Mucositis

Impact of Keratinized Mucosa Augmentation Following Non-surgical Therapy on Treatment Outcomes of Peri-implant Mucositis.

This study aims to observe the effects of keratinized mucosa width on peri-implant tissues by evaluating clinical and biochemical parameters. The main question it aims to answer is:

Would increasing the width of the keratinized mucosa with free gingival graft (FGG) in peri-implant mucositis be beneficial in terms of clinical periodontal parameters and peri-implant crevicular fluid levels of inflammatory cytokines compared to non-surgical therapy alone?

Our study consists of 4 groups:

Peri-implant healthy group with sufficient keratinized mucosa (≥ 2mm) (n=16), peri-implant mucositis group with sufficient keratinized mucosa (n=16), peri-implant mucositis group with insufficient keratinized mucosa (< 2mm) receiving only non-surgical treatment (n=16), peri-implant mucositis group with insufficient keratinized mucosa receiving FGG in addition to non-surgical treatment (n=16). Clinical and biochemical measurements will be recorded at the baseline, 1st month, 4th month and 7th month of the study. Peri-implant crevicular fluid samples will be collected at baseline, 1st month, 4th month and 7th month. IL-1β, RANKL, OPG levels, and RANKL/OPG ratio will be analyzed from collected samples.

Researchers will evaluate the possible benefits of FGG application in addition to non-surgical therapy by comparing the biochemical and clinical changes in areas with and without FGG application in the treatment of peri-implant mucositis.

Study Overview

• Status: Recruiting
• Conditions: Peri-implant Mucositis
• Intervention / Treatment: Procedure: Non-surgical treatment; Procedure: Free gingival graft

• Study Type: Interventional
• Enrollment (Estimated): 64
• 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: Ayse E Selman; Phone Number: +905366393184; Email: aselman@biruni.edu.tr

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Individual dental implants with a fixed prosthetic restoration that has been functional for at least 1 year
• No systemic disease and medication use that may affect periodontal or peri-implanter tissues
• Not receiving periodontal treatment in the last 6 months
• Volunteering to participate in the study

Exclusion Criteria:

• Prosthetic restorations with an excessive contour which do not allow peri-implant pocket measurement
• Being pregnant or breastfeeding,
• Autoimmune and/or inflammatory diseases of the oral cavity,
• Active periodontal disease
• Smokers (≥ 10 cigarettes per day)
• Improperly positioned implants

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Peri-implant healthy group with sufficient keratinized mucosa (≥ 2mm)
Experimental: Peri-implant mucositis group with sufficient keratinized mucosa (≥ 2mm); Only non-surgical therapy will apply	Procedure: Non-surgical treatment; Non-surgical treatment consists of oral hygiene instructions, full mouth supragingival scaling using titanium hand instruments, ultrasonic devices, and subgingival debridement under local anesthesia with titanium curettes and ultrasonic instruments in a single appointment.
Experimental: Peri-implant mucositis group with insufficient keratinized mucosa (< 2mm); Only non-surgical therapy will apply	Procedure: Non-surgical treatment; Non-surgical treatment consists of oral hygiene instructions, full mouth supragingival scaling using titanium hand instruments, ultrasonic devices, and subgingival debridement under local anesthesia with titanium curettes and ultrasonic instruments in a single appointment.
Experimental: Peri-implant mucositis group with insufficient keratinized mucosa (< 2mm) receiving FGG; Free gingival graft will apply following non-surgical therapy	Procedure: Non-surgical treatment; Non-surgical treatment consists of oral hygiene instructions, full mouth supragingival scaling using titanium hand instruments, ultrasonic devices, and subgingival debridement under local anesthesia with titanium curettes and ultrasonic instruments in a single appointment.; Procedure: Free gingival graft; After adequate local anesthesia is achieved. A horizontal incision is placed mucogingival junction level to prepare the recipient bed. A split-thickness flap is raised without disturbing the periosteum. FGG is obtained from the palate, extending from the mesial surface of the second premolar to the middle of the first molar. The graft is shaped and stitched on the recipient surface.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inflammatory parameter levels in peri-implant crevicular fluid	Peri-implant crevicular fluid samples will be collected from 3 sites (mesiobuccal, buccal, distobuccal) of the implants using methylcellulose strips PerioPaper® (Oralflow Inc., Smithtown, NY, USA) gently placed into the cleansed and dried pocket for 30 sec. Interleukin-1beta, RANKL and OPG levels and RANKL/ OPG ratio will be evaluated.	Baseline (prior to therapy)
Inflammatory parameter levels in peri-implant crevicular fluid	Peri-implant crevicular fluid samples will be collected from 3 sites (mesiobuccal, buccal, distobuccal) of the implants using methylcellulose strips PerioPaper® (Oralflow Inc., Smithtown, NY, USA) gently placed into the cleansed and dried pocket for 30 sec. Interleukin-1beta, RANKL and OPG levels and RANKL/ OPG ratio will be evaluated.	1st month
Inflammatory parameter levels in peri-implant crevicular fluid	Peri-implant crevicular fluid samples will be collected from 3 sites (mesiobuccal, buccal, distobuccal) of the implants using methylcellulose strips PerioPaper® (Oralflow Inc., Smithtown, NY, USA) gently placed into the cleansed and dried pocket for 30 sec. Interleukin-1beta, RANKL and OPG levels and RANKL/ OPG ratio will be evaluated.	4th month
Inflammatory parameter levels in peri-implant crevicular fluid	Peri-implant crevicular fluid samples will be collected from 3 sites (mesiobuccal, buccal, distobuccal) of the implants using methylcellulose strips PerioPaper® (Oralflow Inc., Smithtown, NY, USA) gently placed into the cleansed and dried pocket for 30 sec. Interleukin-1beta, RANKL and OPG levels and RANKL/ OPG ratio will be evaluated.	7th month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plaque index (Silness & Löe, 1964)	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 (prior to therapy)
Plaque index (Silness & Löe, 1964)	Plaque index (Silness & Löe, 1964): 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 (Silness & Löe, 1964)	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	4th month
Plaque index (Silness & Löe, 1964)	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	7th month
Gingival Index ( Löe & Silness,1963)	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 ( Löe & Silness,1963)	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 ( Löe & Silness,1963)	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	4th month
Gingival Index ( Löe & Silness,1963)	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	7th month
Bleeding on probing (Ainamo & Bay 1975)	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 (prior to therapy)
Bleeding on probing (Ainamo & Bay 1975)	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 (Ainamo & Bay 1975)	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.	4th month
Bleeding on probing (Ainamo & Bay 1975)	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.	7th 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.	Baseline (prior to therapy)
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.	4th 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.	7th 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 (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
Probing 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.	4th month
Probing 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.	7th month

Collaborators and Investigators

• Sponsor: Biruni University
• Investigators: Principal Investigator: Ayse E Selman, Biruni University

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2024
• Primary Completion (Estimated): March 10, 2025
• Study Completion (Estimated): May 10, 2025

Study Registration Dates

• First Submitted: March 5, 2024
• First Submitted That Met QC Criteria: March 5, 2024
• First Posted (Actual): March 12, 2024

Study Record Updates

• Last Update Posted (Actual): May 7, 2024
• Last Update Submitted That Met QC Criteria: May 6, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Stomatognathic Diseases; Mouth Diseases; Mucositis
• Other Study ID Numbers: 2015-KAEK-80-23-25

Drug and device information, study documents

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