Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID06553677

Clinical Evaluation of Tunneled Coronally Advanced Flap Versus Coronally Advanced Flap With Connective Tissue Graft in Treatment of Isolated RT2 Gingival Recession Sites

Led by Cairo University · Updated on 2024-08-14

22

Participants Needed

1

Research Sites

17 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This clinical trial is focused on patients with isolated RT2 gingival recession sites, a common type of gum recession affecting the root surface of teeth. Researchers are evaluating two surgical techniques combined with connective tissue grafts—the tunneled coronally advanced flap and the coronally advanced flap—to reduce the depth of gingival recession. The goal is to address issues such as dentin sensitivity, non-carious cervical lesions, and improve esthetic outcomes, especially since RT2 recessions are quite prevalent yet understudied in randomized trials. The study compares two treatment approaches: the tunneled coronally advanced flap (TCAF) and the coronally advanced flap (CAF), both combined with connective tissue grafts. TCAF involves carefully elevating the gum flap with minimal trauma to preserve blood supply and papilla integrity, while CAF uses a trapezoidal flap that includes split and full-thickness sections for root coverage. Both procedures involve inserting a connective tissue graft beneath the flap to promote healing. These interventions aim to combine advantages of access, graft stability, and vascularization to improve clinical and esthetic results. Participants will be monitored over a 6-month period to assess outcomes such as gingival recession depth reduction, root coverage percentages, gingival thickness, keratinized tissue width, and esthetic scores. Additional assessments include patient-reported pain and satisfaction over 2 weeks and 6 months. The study involves a randomized allocation to one of the two treatment groups, with single masking. The total involvement includes surgical procedures, follow-up visits, and clinical measurements to evaluate the effectiveness of the treatments and patient experience.

CONDITIONS

Brief Title

Clinical Evaluation of Tunneled Coronally Advanced Flap v.s Coronally Advanced Flap With Graft for Gingival Recession

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients age 18 years or older
  • Isolated recession defect classified as RT2
  • Patients with healthy systemic condition
  • Clinical indication and/or patient request for root coverage
  • O'Leary index less than 20%
Not Eligible

You will not qualify if you...

  • Pregnant females
  • Smokers: a contraindication for any plastic periodontal surgery
  • Unmotivated and uncooperative patients with poor oral hygiene
  • Patients with habits that may compromise the longevity and affect the result of the study such as alcoholism or parafunctional habits

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Surgery and recovery period of 2 weeks

Participants receive a surgical procedure to treat isolated RT2 gingival recession sites using either the tunneled coronally advanced flap with connective tissue graft or the coronally advanced flap with connective tissue graft technique.

1 surgical visit and follow-up visits during the first 2 weeks

Follow-up

Duration - Up to 6 months after treatment

Participants are monitored for clinical outcomes including root coverage, gingival thickness, esthetic scores, post-operative pain, and patient satisfaction.

Visits at 2 weeks and periodic visits up to 6 months

Trial Site Locations

Total: 1 location

1

Faculty of Dentistry, Cairo University

Cairo, Egypt

Actively Recruiting

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Research Team

O

Omar H Sallam, MSc

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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