UnknownNot Applicable

ASSESSMENT OF CLINICAL PARAMETERS AND LASER DOPPLER FLOWMETRY FOR THE TREATMENT OF MULTIPLE GENGIVAL RECESSIONS WITH TWO TYPES OF SUBEPITELIAL CONNECTIVE GRAFT: RANDOMIZED CLINICAL STUDY

Brazil20 participantsStarted 2017-02-03

Plain-language summary

Subepithelial connective tissue graft (SCTG) is considered the gold standard treatment for root coverage in Miller Class I and II single gingival recession. Therefore, scientific evidence is limited for multiple gingival recessions, only with extrapolation from single-tooth data. Depending on area and depth during the removal of the graft from palate, connective tissue presents different anatomic characteristics, geometric shapes and histological composition. Possibly different types of SCTGs present distinct volumetric stability and physiological process of revascularization. This randomized, split-mouth, double blind clinical trial aim to evaluate periodontal parameters (complete root coverage, gingival recession depth and width, gingival thickness, width of keratinized tissue, probing depth, clinical attachment, plaque and bleeding index) and gingival blood flow in recipient sites, comparing sites that received SCTG from palatal area with predominance of lamina propria and predominance of submucosa. Clinical measurements will be evaluated at baseline and 3, 6 and 12 months after surgical procedure. Blood flow flowmetry with laser doppler (LDF) will be analyzed at baseline and 3, 7,14 and 28 days after surgery. Participants will be invited to answer a questionnaire of aesthetic satisfaction and symptoms of pain and discomfort. Two experienced periodontists blind to experimental groups will be invited to observe the clinical outcomes and answer an aesthetic questionnaire. Data analysis will be performed by paired t-test if follow normal distribution or Wilcoxon if follow nonnormal distribution with significance level of 5% (p \<0.05).

Who can participate

Age range

18 Years – 70 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: clinical diagnosis of multiple gingival recessions with at least one gingival recession ≥ 2 mm, including canines and premolars; (2) Miller class I and II gingival recession areas; (3) non-abrasive, erosive or carious root surfaces (4) unrotated, non-extruded and non-movable teeth (5) systemically healthy patients without contraindication to periodontal surgical procedures - Exclusion Criteria:: smokers, pregnant women and infants, patients with a history of periodontal disease or recurrent abscess formation, patients previously submitted to surgical procedures for root coverage, patients taking anti-convulsant drugs, antihypertensives, contraceptives or immunosupressors, pacientes with low oral hygiene (plaque and bleeding index over 20%) \-

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

Total root coverage measured with a periodontal probe in mm

Timeframe: One year

Trial details

NCT IDNCT03207971

SponsorUniversity of Sao Paulo

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-10

Contact for this trial

Ricardo R Eustachio, Master of Science student

+55 31 988916111 ricardorabelo@usp.br

View on ClinicalTrials.gov More Gingival Recession, Generalized trials