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Three-dimensional Changes in Free Gingival Grafts Around Dental Implants

StatusRecruiting
PhaseNot applicable
Started2024-11-10
View on ClinicalTrials.gov ↗
Record status
This record was last updated November 27, 2024 (before its estimated July 10, 2025 completion). Its status may not reflect the trial's current state.

Amendment history

2024-11-25
Not Yet Recruiting→Recruiting Study Identification, Study Status, Study Description, Arms and Interventions, Eligibility, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2025-03-10→2025-07-10
Completion date2025-05-10→2025-07-10
Start dateestimated 2024-05-10→confirmed 2024-11-10
Study sites0→1
Eligibility criteria-80 characters
[...] mm keratinized gingiva on the vestibular side of the implant or scheduled SDG requirement prior to implant No systemic disease and medication use that may affect soft [...] ry diseases of the oral cavity, Active periodontal disease, Smokers (≥ 10 cigarettes per day) Incorrectly positioned implants
2024-05-03
Study Status, Outcome Measures v1
Secondary endpoints25 entries, revised
Plaque index (Silness & Löe, 1964) Plaque index (Silness & Löe, 1964) Plaque index (Silness & Löe, 1964) Plaque index (Silness & Löe, 1964) Gingival Index ( Löe & Silness,1963) Gingival Index ( Löe & Silness,1963) Gingival Index ( Löe & Silness,1963) Gingival Index ( Löe & Silness,1963) Bleeding on probing (Ainamo & Bay 1975) Bleeding on probing (Ainamo & Bay 1975) Bleeding on probing (Ainamo & Bay 1975) Bleeding on probing (Ainamo & Bay 1975)
2024-05-01
Original filing
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 Details
NCT Number NCT06399198
Lead Sponsor Biruni University
Conditions Insufficient Keratinized Gingiva
Enrollment 32 participants
Start Date 2024-11-10
Primary Completion 2025-07-10 (estimated)
Study Completion 2025-07-10 (estimated)
Updated on ClinicalTrials.gov 2024-11-27