The Clinical Usage of a Free Gingival Graft Combined With Frenotomy in Patients With High Frenal Attachment
1 other identifier
interventional
12
0 countries
N/A
Brief Summary
In patients with high frenal attachment will placement of free gingival graft combined with frenotomy result in gain of width of keratinized gingiva, decrease relapse, improve mucosal healing and have acceptable postoperative pain?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Oct 2023
Shorter than P25 for phase_4
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 Start
First participant enrolled
October 1, 2023
CompletedFirst Submitted
Initial submission to the registry
October 21, 2023
CompletedFirst Posted
Study publicly available on registry
October 26, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2024
CompletedOctober 26, 2023
October 1, 2023
5 months
October 21, 2023
October 21, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Width of keratinized tissue
It will be measured using periodontal probe at T1, T2, T3 and T4
T1: 5days post-surgery, T2:14 days post-surgery, T3: 2months post-surgery & T4: 3months post-surgery.
Secondary Outcomes (3)
Mucosal healing
T1: 5days post-surgery, T2:14 days post-surgery, T3: 2months post-surgery
Post-operative pain
T2:14 days post-surgery.
Relapse
T4: 3months post-surgery.
Study Arms (1)
Combining Free Gingival Graft with frenotomy procedure
EXPERIMENTALevaluate the usage of free gingival graft combined with frenotomy in order to measure the gain in the width of keratinized gingiva, relapse, mucosal healing and postoperative pain.
Interventions
The aim of the study is to evaluate the usage of free gingival graft combined with frenotomy in order to measure the gain in the width of keratinized gingiva, relapse, mucosal healing and postoperative pain.
Eligibility Criteria
You may qualify if:
- Ages 18-40 years old
- Systemically healthy
- Gingival and plaque index \<10
- Good oral hygiene
- Highly attached mandibular labial frenum.
- Narrow sulcus depth
- Thin gingival phenotype
You may not qualify if:
- Smokers
- Poor oral hygiene
- Patient with a physical disability that hinders the upkeep of good oral hygiene measures.
- Taking any medications that could affect healing
- Any systemic diseases that delay wound healing.
- Deep sulcus
- Thick gingival phenotype
- Pervious frenal procedures
- Pregnant or lactating females
- Pervious periodontal surgery within the last 6 months before the start of the trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Officials
- STUDY DIRECTOR
Manal Hosny, Professor
Cairo University
- STUDY CHAIR
Nada Zazou, Ass Lecturer
MSA University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Master degree student, periodontology department, faculty of dentistry, Cairo University.
Study Record Dates
First Submitted
October 21, 2023
First Posted
October 26, 2023
Study Start
October 1, 2023
Primary Completion
March 1, 2024
Study Completion
August 1, 2024
Last Updated
October 26, 2023
Record last verified: 2023-10