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

NCT ID: NCT06588998

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-01

Study Completion Date

2024-12-30

Brief Summary

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Peri-implant soft tissue dehiscences represent a common complication in implant dentistry, often leading to esthetic and functional challenges. Current treatment options, including Xengenic cortical membranes and connective tissue graft with coronally advanced flap, aim to promote soft tissue regeneration and improve clinical outcomes. However, there is a need for comparative studies to determine the optimal treatment modality for peri-implant soft tissue dehiscences.

Detailed Description

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Aim: Comparing the effectiveness and patient outcomes of Xengenic cortical membranes versus connective tissue graft with coronally advanced flap for the treatment of peri-implant soft tissue dehiscences.

Conditions

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Immediate Implant Connective Tissue Graft

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Xengenic Cortical membranes

Group Type EXPERIMENTAL

Xengenic Cortical membranes

Intervention Type DEVICE

soft tissue surgery around dental implant dehiscence

connective tissue graft

Group Type ACTIVE_COMPARATOR

connective tissue graft

Intervention Type PROCEDURE

soft tissue surgery around dental implant dehiscence

Interventions

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Xengenic Cortical membranes

soft tissue surgery around dental implant dehiscence

Intervention Type DEVICE

connective tissue graft

soft tissue surgery around dental implant dehiscence

Intervention Type PROCEDURE

Other Intervention Names

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Osteobiol ,flexible xenograft cortical sheet from Technoss,USA

Eligibility Criteria

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Inclusion Criteria

* Adults (20-50) years old. •peri-implant soft tissue dehiscence . •Thin gingival phenotype. •Optimal compliance as evidenced by no missing treatment appointments and positive attitude towards oral hygiene.

Exclusion Criteria

* •Medically compromised patients and systemic conditions precluding implant and periodontal surgery. •Smokers, diabetics, pregnant or lactating women. •History of chemotherapy, radiotherapy in head and/or neck region. •Bisphosphonate therapy.
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Amr Anwar Mohamed Ellithy Yousef

OTHER

Sponsor Role lead

Responsible Party

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Amr Anwar Mohamed Ellithy Yousef

assistant lecturer

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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TantaU

Tanta, Gharbia Governorate, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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amr anwar ellithy, MSC

Role: CONTACT

00201066767062

bassem nabil elfahl, PHD

Role: CONTACT

+20 114 009 0390

Other Identifiers

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peri-implant_1

Identifier Type: -

Identifier Source: org_study_id

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