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

NCT06636461 | Not Yet Recruiting

• 1 other identifier: Assessment of dimensional chan
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hopeless Tooth

Keywords

hopeless tooth lesion or affected periodontium

Outcome Measures

Primary Outcomes (1)

• Alveolar ridge hight (bone quantity )

  By CBCT

  Alveolar ridge hight (bone quantity ) by CBCT after 3-6 months

Secondary Outcomes (1)

• Alveolar ridge width.

  Alveolar ridge width. by CBCT after 3-6 months

Study Arms (2)

microfragmented adipose tissue

EXPERIMENTAL

microfragmented adipose tissue loaded on allograft on ridge preservation

Procedure: microfragmented adipose tissue loaded on allograft

allograft

ACTIVE COMPARATOR

allograft only on ridge preservation

Procedure: microfragmented adipose tissue loaded on allograft

Interventions

microfragmented adipose tissue loaded on allograft PROCEDURE

microfragmented adipose tissue loaded on allograft on ridge preservation

allograft; microfragmented adipose tissue

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo Universty

Cairo, Giza Governorate, Egypt

Location

Central Study Contacts

maha alnahdi, BDS

CONTACT

01145684357; maha.alnahdi@dentistry.cu.edu.eg

hesham elhawary, prof

CONTACT

01144446373; hesham.elhawary@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: September 2, 2024
• First Posted: October 10, 2024
• Study Start: November 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: February 1, 2025
• Last Updated: October 10, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: After 6 months, patients will be evaluated histomorphometrically via core biopsy at the time of implant placement and radiographically via assessment of ridge height on CBCT. 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 6 months postoperatively.

Locations

EG (1)