Subepithelial Connective Tissue Graft Versus Amniotic Chorion Membrane for Peri-implant Mucosal Thickness Enhancement

NCT ID: NCT06295653

Last Updated: 2024-03-06

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-01

Study Completion Date

2025-04-30

Brief Summary

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The objective of this study will be to assess the efficacy of the peri-implant mucosal thickness enhancement following either subepithelial connective tissue grafts or Amnion Chorion Membrane placed simultaneously with dental implant placement.

Detailed Description

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Conditions

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Dental Implant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Autogenous Subepithelial Connective Tissue Graft plus dental implants

implant placement and augment Subepithelial Connective Tissue Graft and suture implant site

Group Type ACTIVE_COMPARATOR

implant placement and soft tissue augmentation with Autogenous Subepithelial Connective Tissue Graft or Amniotic Chorion Membrane

Intervention Type PROCEDURE

assess the efficacy of the peri-implant mucosal thickness enhancement following either subepithelial connective tissue grafts or Amniotic Chorion Membrane placed simultaneously with dental implant placement.

Amniotic Chorion Membrane plus dental implant

implant placement and augment Amniotic Chorion Membrane and suture implant site

Group Type ACTIVE_COMPARATOR

implant placement and soft tissue augmentation with Autogenous Subepithelial Connective Tissue Graft or Amniotic Chorion Membrane

Intervention Type PROCEDURE

assess the efficacy of the peri-implant mucosal thickness enhancement following either subepithelial connective tissue grafts or Amniotic Chorion Membrane placed simultaneously with dental implant placement.

Interventions

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implant placement and soft tissue augmentation with Autogenous Subepithelial Connective Tissue Graft or Amniotic Chorion Membrane

assess the efficacy of the peri-implant mucosal thickness enhancement following either subepithelial connective tissue grafts or Amniotic Chorion Membrane placed simultaneously with dental implant placement.

Intervention Type PROCEDURE

Other Intervention Names

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measure mucosal thickness with probe connective tissue grafting from palate

Eligibility Criteria

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Inclusion Criteria

* Patients with good systemic health with no contraindication for periodontal surgery.
* No history of any medications in the previous 6 months that may interfere with periodontal tissue health or healing.
* Ability to maintain good oral hygiene as evidenced in recall visits.
* Aged 30 to 55 years.
* Stable periodontal condition and missing one single tooth (maxillary anterior teeth and premolars) with adjacent teeth present and thin mucosal phenotype (\< 2mm bucco- lingual thickness).

Exclusion Criteria

* Medically compromised patients and systemic conditions precluding periodontal surgery.
* Smokers.
* Severe hematologic disorders (e.g., hemophilia or leukemia), uncontrolled infectious or metabolic diseases that could compromise normal healing, liver, or kidney dysfunction/failure.
* Patients subjected to irradiation in the head and neck area.
* Patients treated or under treatment with intravenous amino bisphosphonates.
* Patient affected by active periodontitis or has poor oral hygiene and motivation.
* Uncontrolled diabetes mellitus.
* Pregnant women or planning become pregnant, and nursing mothers.
Minimum Eligible Age

30 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Hamdy Helal

Lecturer of Oral Medicine, Periodontology, Oral Diagnosis & Radiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculity of Dentistry Tanta University

Tanta, Elgarbia, Egypt

Site Status

Countries

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Egypt

Central Contacts

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ahmed a abdelsayed

Role: CONTACT

+201090609989

Facility Contacts

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Faten a Seddiq, Faculty Dean

Role: primary

3335631 ext. +20

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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7-23

Identifier Type: -

Identifier Source: org_study_id

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