NCT06399198

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 1, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 3, 2024

Completed
6 months until next milestone

Study Start

First participant enrolled

November 10, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2025

Completed
Last Updated

November 27, 2024

Status Verified

November 1, 2024

Enrollment Period

8 months

First QC Date

May 1, 2024

Last Update Submit

November 25, 2024

Conditions

Insufficient Keratinized Gingiva

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (25)

  • Plaque index

    Baseline

  • Plaque index

    1st month

  • Plaque index

    3rd month

  • Plaque index

    6th month

  • Gingival Index

    Baseline (prior to therapy)

  • +20 more secondary outcomes

Study Arms (2)

smoker

EXPERIMENTAL
Procedure: Free gingival graft

non-smoker

EXPERIMENTAL
Procedure: Free gingival graft

Interventions

Free gingival graftPROCEDURE

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.

non-smokersmoker

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biruni University

Istanbul, Turkey (Türkiye)

RECRUITING

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
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

May 1, 2024

First Posted

May 3, 2024

Study Start

November 10, 2024

Primary Completion

July 10, 2025

Study Completion

July 10, 2025

Last Updated

November 27, 2024

Record last verified: 2024-11

Locations

TU(1)