NCT06305000

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
4mo left

Started Mar 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress86%
Mar 2024Sep 2026

First Submitted

Initial submission to the registry

March 5, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 12, 2024

Completed
15 days until next milestone

Study Start

First participant enrolled

March 27, 2024

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2026

Last Updated

February 10, 2026

Status Verified

February 1, 2026

Enrollment Period

2.5 years

First QC Date

March 5, 2024

Last Update Submit

February 6, 2026

Conditions

Peri-implant Mucositis

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (20)

  • Plaque index (Silness & Löe, 1964)

    Baseline (prior to therapy)

  • Plaque index (Silness & Löe, 1964)

    1st month

  • Plaque index (Silness & Löe, 1964)

    4th month

  • Plaque index (Silness & Löe, 1964)

    7th month

  • Gingival Index ( Löe & Silness,1963)

    Baseline (prior to therapy)

  • +15 more secondary outcomes

Study Arms (3)

Peri-implant healthy group with sufficient keratinized mucosa (≥ 2mm)

NO INTERVENTION

Peri-implant mucositis group with sufficient keratinized mucosa (≥ 2mm)

EXPERIMENTAL

Only non-surgical therapy will apply

Procedure: Non-surgical treatment

Peri-implant mucositis group with insufficient keratinized mucosa (< 2mm) receiving FGG

EXPERIMENTAL

Free gingival graft will apply following non-surgical therapy

Procedure: Non-surgical treatmentProcedure: Free gingival graft

Interventions

Non-surgical treatmentPROCEDURE

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.

Peri-implant mucositis group with insufficient keratinized mucosa (< 2mm) receiving FGGPeri-implant mucositis group with sufficient keratinized mucosa (≥ 2mm)
Free gingival graftPROCEDURE

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.

Peri-implant mucositis group with insufficient keratinized mucosa (< 2mm) receiving FGG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biruni University

Istanbul, Turkey (Türkiye)

RECRUITING

Study Officials

  • Ayse E Selman

    Biruni University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ayse E Selman

CONTACT

+905366393184aselman@biruni.edu.tr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

March 5, 2024

First Posted

March 12, 2024

Study Start

March 27, 2024

Primary Completion (Estimated)

September 10, 2026

Study Completion (Estimated)

September 10, 2026

Last Updated

February 10, 2026

Record last verified: 2026-02

Locations

TU(1)