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The Comparison of the Efficacy of Gingival Unit Graft With Connective Tissue Graft in Root Coverage

The Comparison of the Efficacy of Gingival Unit Graft With Connective Tissue Graft in Root Coverage: A Randomized Split-Mouth Clinical Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04637451
Enrollment
16
Registered
2020-11-19
Start date
2015-07-01
Completion date
2016-07-30
Last updated
2020-11-19

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

Conditions

Gingival Recession, Periodontal Diseases

Brief summary

The purpose of the study is to compare the clinical effectiveness of gingival unit graft (GUG) and connective tissues graft (CTG) in Miller's class I and II gingival recession.

Detailed description

Patients who accept the study have provided information about the study and required a written informed consent form. The clinical effectiveness of two different periodontal surgical techniques (gingival unit graft and connective tissue graft) in gingival recessions will be evaluated. Periodontal measurements (gingival recession, keratinized gingiva height) and patient-reported outcomes (intra and post-operative pain, patient satisfaction and hypersensitivity) are defined.

Interventions

PROCEDURERoot coverage treatment

Gingival unit graft Connective tissue graft

Sponsors

Okan University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Systemic healthy individuals * Presence Miller's class I and II gingival recession in the anterior and premolar teeth

Exclusion criteria

* Age \<18 years * Pregnancy * Lactation * Any cardiovascular, renal or hepatic conditions * History of periodontal surgery * Tooth mobility * Presence of probing depth \>3 mm and caries or restorations in the teeth undergoing treatment

Design outcomes

Primary

MeasureTime frameDescription
Change from Baseline Gingival Recession Depth at 6 monthBaseline and month 6.The gingival recession depth consists of the distance from the cement-enamel junction to the most apical extension of the gingival margin. The measurement is recorded in millimeters. Change= (6 month score-baseline score)
Change from Baseline Keratinized Gingiva Height at 6 monthBaseline and month 6.Keratinized gingiva height, measured as the distance from the gingival margin to the mucogingival line. The measurement is recorded in millimeters. Change= (6 month score-baseline score)

Secondary

MeasureTime frameDescription
Change from Baseline Root Hypersensitivity at 6 monthBaseline and month 6.Root hypersensitivity at baseline and post-operative 6 month utilizing a visual numerical scale (VNS) test are defined. Possible scores range from (0=no sensitive and 10= worst possible sensitive). Change= (6 month score-baseline score)
Change from Baseline Patient Satisfaction at 6 monthBaseline and month 6.The patient satisfaction with the gingiva position, structure and color of the gingival recessions sites utilizing a VNS test (0=not satisfied and 10=very satisfied) are defined. Possible scores range from 0 (not satisfied) to 10 (very satisfied). Change= (6 month score-baseline score)
Change from Baseline Pain at 1 weekBaseline and week 1.Pain perception of the surgery at intra and post-operative period (week 1) utilizing a VNS test are defined. Possible scores range from 0 (no pain) to 10 (worst possible pain). Change= (1 week score-baseline score)
Change from Baseline Pain at 2 weekBaseline and week 2.Pain perception of the surgery at intra and post-operative period (week 2) utilizing a VNS test are defined. Possible scores range from 0 (no pain) to 10 (worst possible pain). Change= (2 week score-baseline score)

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026