Gingival Recession (RT1) Treatment With Different Gingival Augmentation Surgeries

Gingival Recession Clinical Trial

Official title:

Gingival Recession (RT1) Treatment With Different Gingival Augmentation Surgeries Compared With Untreated Contralateral Sites: A Randomized Controlled Clinical Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05688293
• Other study ID #: PER 5213005
• Status: Recruiting
• Phase: N/A
• Start date: March 5, 2024
• Est. completion date: March 1, 2025

Study information

• Verified date: January 2024
• Source: Misr International University
• Contact: Zainab Hafez, Lecturer
• Phone: +01221334637
• Email: zeinab.hafez[@]miuegypt.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 1, 2025
• Est. primary completion date: January 20, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Gingival Recession

Intervention

Procedure:
• Connective tissue graft
non-surgical periodontal treatment and connective tissue graft
• Free gingival graft
will receive non-surgical periodontal treatment and partially de-epithelized free gingival graft
• Non surgical
non-surgical periodontal treatment only

Locations

Country	Name	City	State
Egypt	Faculty of oral and dental medicine, Misr international university	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Misr International University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gingival phenotype change	determination of the change in gingival thickness in mm using periodontal probe	at baseline 3,6 and 12 months
Secondary	Keratinized tissue width	determination of Keratinized tissue width in mm using periodontal probe	at baseline 3,6 and 12 months
Secondary	Root coverage esthetic score (RES)	It is a scoring system to assess the level of gingival margin (GM),marginal tissue contour (MTC),Soft tissue texture, Mucogingival alignment (MGJ),Gingival color The score is 0,1 and 3 where 0 is the minimum and 3 is the maximum	at baseline 3,6 and 12 months