NCT06250179

Brief Summary

The purpose of this clinical trial is planned to be conducted with 45 individuals aged between 18-65, with Cairo type I gingival recession and patients requiring free gingival surgery. It was aimed to investigate when the palatal mucosa will return to its previous volume in the donor area and the effect of smoking. The main questions it aims to answer are:

  • Evaluation of 3D volume change of the palatal donor area from which free gingival graft was taken
  • determining how long it takes for the palatal mucosa to regain its original shape and thickness Participants will be asked to comply with postoperative recommendations and pay attention to oral hygiene. If there is a comparison group: Researchers use it to see if smoking affects the volume change in the donor area. They will compare non-smokers with clinically healthy gums, 'light' smokers who report smoking less than 5 cigarettes per day and patients with clinically healthy gums, and ex-smokers with clinically healthy gums who have not smoked for 5 years.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not 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

February 1, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 8, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

July 10, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

July 25, 2024

Status Verified

July 1, 2024

Enrollment Period

2 months

First QC Date

February 1, 2024

Last Update Submit

July 23, 2024

Conditions

Free Gingival Graft Volume Change

Keywords

free gingival graftcigarette3D scanning

Outcome Measures

Primary Outcomes (1)

  • Examination of volume change in the palatal donor region in smoking and non-smoking patients

    It was aimed to examine the volume change among the 3 groups in our study by looking at its connection with smoking. A study plan was created by comparing the 3D shape device on which the scans were made with Geomatic Control X and looking at the volume change.

    3 months

Study Arms (3)

Non-smoking patients

EXPERIMENTAL

The patient will receive a free gingival graft for insufficient keratinized gingival height.

Procedure: free gingiva graft surgery

'Light' smokers who report smoking less than 5 cigarettes per day

ACTIVE COMPARATOR

The patient will receive a free gingival graft for insufficient keratinized gingival height.

Procedure: free gingiva graft surgery

Non-smoker for 5 years, quit smoking patients

ACTIVE COMPARATOR

The patient will receive a free gingival graft for insufficient keratinized gingival height.

Procedure: free gingiva graft surgery

Interventions

free gingiva graft surgeryPROCEDURE

For insufficient gingival height in patients, the free gingival graft taken from the palate will be sutured to the relevant area.

'Light' smokers who report smoking less than 5 cigarettes per dayNon-smoker for 5 years, quit smoking patientsNon-smoking patients

Eligibility Criteria

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

You may qualify if:

  • Volunteers aged 18 and over
  • Treatments with Cairo type I gingival treatment and requiring free gingival surgery
  • There is no psychiatric, mental or physical disability
  • My son has not received periodontal treatment within 6 months.
  • Being systemically healthy
  • Having at least 20 teeth in your entire mouth
  • Getting diagnosed with healthy gums
  • Not using any medication
  • Not pregnant
  • Not having used any antibiotics, anti-inflammatory or any other medication that will swell the periodontal tissues in the last 6 months for any reason.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Necmettin Erbakan Üniversitesi

Konya, 42090, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SCREENING
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
research assistant

Study Record Dates

First Submitted

February 1, 2024

First Posted

February 8, 2024

Study Start

July 10, 2024

Primary Completion

September 1, 2024

Study Completion

December 1, 2024

Last Updated

July 25, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will share

Free gingiva in non-smoking patients with insufficient keratinized gingival height and clinically healthy gingiva, 'light' smokers who report smoking less than 5 cigarettes per day and patients with clinically healthy gingiva, and patients with healthy gingiva who have quit smoking and have not smoked for 5 years. It was aimed to evaluate the 3D volume change of the grafted palatal donor area, to determine the volumetric change in the donor area and how long it took for the palatal mucosa to regain its original shape and thickness.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
February 2024-July 2024
Access Criteria
search

Locations

TU(1)