Actively Recruiting

Phase 2
Age: 20Years - 50Years
All Genders
ID06588998

Xengenic Cortical Membranes Versus Connective Tissue Graft With Coronally Advanced Flap for Peri-implant Soft Tissue Dehiscences: A Randomized, Controlled Clinical Trial

Led by Amr Anwar Mohamed Ellithy Yousef · Updated on 2024-09-19

20

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Peri-implant soft tissue dehiscences are common problems in implant dentistry that cause challenges for both appearance and function. Researchers are comparing two treatments: Xengenic cortical membranes and connective tissue graft with coronally advanced flap, to find which is better for improving soft tissue around implants. This is a randomized, controlled clinical trial aimed at evaluating outcomes and patient experiences with these treatments. The trial involves two groups receiving different soft tissue surgeries around dental implant dehiscence. One group is treated with Xengenic cortical membranes, a device used to support tissue regeneration. The other group receives a connective tissue graft combined with a coronally advanced flap procedure. Both treatments are provided under controlled conditions as part of the study. Participants will be monitored over six months to assess changes in peri-implant soft tissue thickness, which is the main outcome measure. Researchers will also evaluate the pink esthetic score to understand the appearance improvements. Throughout the study, participants' compliance and oral hygiene will be tracked to support treatment success. The study duration includes regular visits and assessments for accurate measurement of the results.

CONDITIONS

Brief Title

Xengenic Cortical Membranes Versus Connective Tissue Graft With Coronally Advanced Flap for the Treatment of Peri-implant Soft Tissue Dehiscences: A Randomized, Controlled Clinical Trial

Who Can Participate

Age: 20Years - 50Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 20 to 50 years
  • Presence of peri-implant soft tissue dehiscence
  • Thin gingival tissue type
  • Willingness and ability to attend all treatment appointments
  • Positive attitude and compliance with oral hygiene instructions
Not Eligible

You will not qualify if you...

  • Medically compromised patients or those with conditions preventing implant or periodontal surgery
  • Smokers
  • People with diabetes
  • Pregnant or breastfeeding women
  • History of chemotherapy or radiotherapy in the head or neck area
  • Current or past use of bisphosphonate therapy

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.

Surgery and Immediate Post-operative Care

Duration - Up to a few days around surgery

Participants undergo soft tissue surgery around dental implant dehiscence using either Xengenic cortical membranes or connective tissue graft with coronally advanced flap.

1 surgery visit (in-person) and immediate recovery visits

Post-operative Follow-up

Duration - 6 months

Participants are monitored for healing and outcomes related to the surgery, including soft tissue thickness and esthetic evaluation.

Approximately 6 post-operative visits

Trial Site Locations

Total: 1 location

1

TantaU

Tanta, Gharbia Governorate, Egypt

Actively Recruiting

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Research Team

A

amr anwar ellithy, MSC

B

bassem nabil elfahl, PHD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

2

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