Increasing the Thickness of Soft Tissues in the Esthetic Zone Around Implants (NCT05551962) | Clinical Trial Compass
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Increasing the Thickness of Soft Tissues in the Esthetic Zone Around Implants
Russia30 participantsStarted 2022-06-09
Plain-language summary
This is an interventional prospective randomized clinical trial (RCT) in parallel groups. This study is aimed at detecting a difference in the increase in the thickness of soft tissues of at least 0.3 mm between the two groups (the standard deviation \[SD\] of 0.3 mm and the average value of 1.2 mm was borrowed from an article published by Cairo F et al., 2017). Using SampleSizeCalculator, it was calculated that the number of patients in each group should be 14 (alpha = 0.05; power = 80%). This number was increased by 10%, taking into account possible exceptions from the study. The sample size is 30 patients who will be randomly divided into two groups depending on the surgical intervention used. First group - patients will undergo increasing the thickness of the mucous membrane using free connective tissue graft from tuberosity area of the maxilla or palate. Second group - patients will undergo increasing the thickness of the mucous membrane using collagen matrix "Fibro-Gide" (Geistlich Pharma AG, Bahnhofstrasse 40, 6110 Wolhusen, Switzerland; registration in Russia 19.08.2020 No FSZ-20207/11765). In the postoperative period the value of soft tissue thickness gain, severity of pain syndrome, collateral edema, Doppler flowmetry, probing depth, soft tissue aesthetics, keratinized mucosa width and quality of life will be assessed. In addition, after 3 months simultaneously with installation of gingiva formers biopsy specimens will be sampled with mucotome in the area of the intervention followed by histomorphometric analysis of the obtained biopsies.
Who can participate
Age range
18 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. The presence of written informed consent of the patient to participate in the study;
. Age from 18 to 45 years;
. The presence of an included defect in the esthetic zone part of maxilla with a sufficient volume of bone tissue;
. Soft tissue thickness \<3 mm on the vestibular side;
. Adjacent teeth without periodontal pathology, the depth of probing should not exceed 3 mm along the entire dentoalveolar furrow;
. Satisfactory level of oral hygiene;
. Patients without concomitant pathology or with concomitant pathology in the compensation stage.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The amount of soft tissue thickness gain
Timeframe: Day 90 compared to the 0th day (initial value)
Trial details
NCT IDNCT05551962
SponsorI.M. Sechenov First Moscow State Medical University