Clinical trial NCT05688293: Gingival Recession (RT1) Treatment With Different Gingival Augmentation Surgeries
Official title: Gingival Recession (RT1) Treatment With Different Gingival Augmentation Surgeries Compared With Untreated Contralateral Sites: A Randomized Controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gingival Recession
Lead sponsor: Misr International University
Sponsor class: OTHER
First posted: 2023-01-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three parallel groups
Primary purpose: TREATMENT

Brief summary: 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.

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

Primary outcomes:
measure: Gingival phenotype change
timeFrame: at baseline 3,6 and 12 months
Secondary outcomes:
measure: Keratinized tissue width
timeFrame: at baseline 3,6 and 12 months
measure: Root coverage esthetic score (RES)
timeFrame: at baseline 3,6 and 12 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of oral and dental medicine, Misr international university
Study officials:
affiliation: Lecturer, faculty of oral and dental medicine misr international university
name: Zainab Hafez, Lecturer
role: PRINCIPAL_INVESTIGATOR
affiliation: Associate professor, faculty of oral and dental medicine misr international university
name: Shahinaz Al ashiry, Asso. Prof
role: STUDY_DIRECTOR
affiliation: Lecturer, faculty of oral and dental medicine misr international universit
name: Yahia Amer, Lecturer
role: PRINCIPAL_INVESTIGATOR
References: