Gingival Recession (RT1) Treatment With Different Gingival Augmentation Surgeries
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Connective tissue graft, Free gingival graft, Non surgical.
- Who it may be relevant to
- Registry conditions: Gingival Recession. Basic parameters: 18 years — 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Gingival Recession (RT1) Treatment With Different Gingival Augmentation Surgeries Compared With Untreated Contralateral Sites: A Randomized Controlled Clinical Study
Overview
Thin gingival phenotype is one of the major causative factors of gingival recession type 1 which can result in hypersensitivity, discomfort, and compromised esthetics. This study assess the efficacy of increasing the gingival thickness from thin gingival phenotype to thick gingival phenotype in the treatment of patients suffering from gingival recession (RT1) and maintenance of results using either connective tissue graft or de-epithelized free gingival graft after non-surgical periodontal debridement compared to non-surgical periodontal debridement alone.
Detailed description
This parallel arm randomized controlled clinical trial study will include systematically free patients with thin gingival phenotype. They will be randomly allocated to three equal groups. Group A (test group, n=10) will receive non-surgical periodontal treatment and connective tissue graft using tunneling technique, Group B (test group, n=10) will receive non-surgical periodontal treatment and partially de-epithelized free gingival graft, while group C (control group, n=10) will receive non-surgical periodontal treatment only. After 3, 6 and 12 months gingival biotype will be clinically assessed (1ry outcome). This parameter will be recorded at baseline, 3, 6 and 12 months. The 2ry outcomes will include recording of recession depth, plaque index, bleeding on probing, keratinized tissue width . Postoperative pain and swelling will be recorded daily by the patient for the 1st two weeks post-surgically. Postoperative instructions and medication will be given to the patient. All readings will be carried out by a calibrated outcome assessor who will be masked. Follow-up will be performed to assess the outcomes and to ensure performing proper oral hygiene. Data collected will be tabulated and statistically analyzed.
Interventions
- Procedure Connective tissue graft
non-surgical periodontal treatment and connective tissue graft - Procedure Free gingival graft
will receive non-surgical periodontal treatment and partially de-epithelized free gingival graft - Procedure Non surgical
non-surgical periodontal treatment only
Primary outcome measures
- Gingival phenotype change [Time frame: at baseline 3,6 and 12 months]
Secondary outcome measures (2)
- Keratinized tissue width [Time frame: at baseline 3,6 and 12 months]
- Root coverage esthetic score (RES) [Time frame: at baseline 3,6 and 12 months]
Eligibility criteria
Inclusion criteria
- Medically free patients (American Society of Anesthesiologists I; ASA I)
- Patients diagnosed with recession (RT1)
- Fair oral hygiene
- Patient accepting to provides an informed consent and the follow-up
Exclusion criteria
- Carious teeth and teeth with periapical infection.
- Patients diagnosed with periodontitis
- Smokers
- Pregnant and lactating females
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Faculty of oral and dental medicine, Misr international university — Cairo
Identifiers
NCT: NCT05688293 · PER 5213005