Assessment of Dimensional Changes Following Grafting With Microfragmented Adipose Tissue Loaded on Allograft on Ridge Preservation

NCT ID: NCT06636461

Last Updated: 2024-10-10

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

2024-11-01

Study Completion Date

2025-02-01

Brief Summary

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Evaluation of maxillary alveolar ridge changes (bone quantity and quality as revealed by radiographic and Histomorphometry ) utilizing microfragmented adipose tissue loaded on allograft versus allograft only for maxillary posterior ridge preservation

Detailed Description

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All patients involved in this study will be divided into two groups; each group will receive a different graft of bone augmentation: Adipose tissue loaded on allograft will be utilized for the study group and allograft only for the control group.

After 3-6 months, assessment of dimensional changes ( RG height \& width) on CBCT is performed and Histomorphometry will be evaluated via core biopsy at the time of implant placement in both groups.

Radiographic assessment that will be achieved by CBCT scan will be used to calculate the changes of bone height and width from base line (1week) to 3-6 months postoperatively.

Conditions

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Hopeless Tooth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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microfragmented adipose tissue

microfragmented adipose tissue loaded on allograft on ridge preservation

Group Type EXPERIMENTAL

microfragmented adipose tissue loaded on allograft

Intervention Type PROCEDURE

microfragmented adipose tissue loaded on allograft on ridge preservation

allograft

allograft only on ridge preservation

Group Type ACTIVE_COMPARATOR

microfragmented adipose tissue loaded on allograft

Intervention Type PROCEDURE

microfragmented adipose tissue loaded on allograft on ridge preservation

Interventions

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microfragmented adipose tissue loaded on allograft

microfragmented adipose tissue loaded on allograft on ridge preservation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients requiring implant treatment after tooth extraction due to either unrestorable caries lesions or affected periodontium.

Age group: above 18 years

• Remaining natural teeth have good periodontal tissue support and occlusion showed sufficient inter arch space for future prosthesis.

Exclusion Criteria

* • General contraindications to implant surgery.

* Subjected to irradiation in the head and neck area less than 1 year before implantation.
* Poor oral hygiene and motivation.
* Severe bruxism or clenching.
* Systemic, immunologic or debilitating diseases that could affect normal bone healing \& local pathosis.
* Treated or under treatment of intravenous amino-bisphosphonates.
* Active infection or severe inflammation in the area intended for implant placement.
* Patients participating in other studies, if the present protocol could not be properly followed.
* Heavy somkers
Minimum Eligible Age

21 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Maha Omar Salem Alnahdi

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cairo Universty

Cairo, Giza Governorate, Egypt

Site Status

Countries

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Egypt

Central Contacts

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maha alnahdi, BDS

Role: CONTACT

01145684357 ext. 01559975945

hesham elhawary, prof

Role: CONTACT

01144446373

Facility Contacts

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hesham Elhawary, prof

Role: primary

01144446373

Maha Alnahdi, BDS

Role: backup

01559975945

Other Identifiers

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Assessment of dimensional chan

Identifier Type: -

Identifier Source: org_study_id

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