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Gingival Recession (RT1) Treatment With Different Gingival Augmentation Surgeries

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05688293
Enrollment
30
Registered
2023-01-18
Start date
2025-02-05
Completion date
2026-03-01
Last updated
2025-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gingival Recession

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.

Interventions

PROCEDUREConnective tissue graft

non-surgical periodontal treatment and connective tissue graft

PROCEDUREFree gingival graft

will receive non-surgical periodontal treatment and partially de-epithelized free gingival graft

PROCEDURENon surgical

non-surgical periodontal treatment only

Sponsors

Misr International University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

the patient won't know the type of the procedures done to him The outcome assessor won't know which group he the is assessing it's results

Intervention model description

Three parallel groups

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Gingival phenotype changeat baseline 3,6 and 12 monthsdetermination of the change in gingival thickness in mm using periodontal probe

Secondary

MeasureTime frameDescription
Keratinized tissue widthat baseline 3,6 and 12 monthsdetermination of Keratinized tissue width in mm using periodontal probe
Root coverage esthetic score (RES)at baseline 3,6 and 12 monthsIt 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

Countries

Egypt

Contacts

Primary ContactZainab Hafez, Lecturer
zeinab.hafez@miuegypt.edu.eg+01221334637
Backup ContactShahinaz Al ashiry, Asso. Prof
shahinaz.elashiry@miuegypt.edu.eg

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026