Assessment of Microfragmented Adipose Tissue Loaded on Bovine Graft Versus Bovine Graft Only on Ridge Preservation.

Tooth Mobility Clinical Trial

Official title:

Radiographic and Histomorphometric Assessment of Microfragmented Adipose Tissue Loaded on Bovine Graft on Ridge Preservation Versus Bovine Graft Only for Subsequent Implant Placement in the Maxillary Posterior Region, a Randomized Clinical Trial.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06457867
• Other study ID #: microfragmented adipose tissue
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: March 1, 2025

Study information

• Verified date: June 2024
• Source: Cairo University
• Contact: Bshaer Bayashot, BDS
• Phone: 01064825199
• Email: bshaer.bayashot[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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 bovine graft will be utilized for the study group and bovine raft only for the control group.

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 from base line (1week) to 6 months postoperatively.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 22
• Est. completion date: March 1, 2025
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

Inclusion Criteria:

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

• Age group: above 21 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 smokers

Related Conditions & MeSH terms

• Tooth Mobility

Intervention

Procedure:
• microfragmented adipose tissue loaded on bovine graft
microfragmented adipose tissue loaded on bovine graft on ridge preservation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantity of bone (vertical bone height)	By CBCT	Quantity of bone (vertical bone height) by CBCT after 6 months
Secondary	Quality of bone	Histological analysis (Core biopsy) Percentage of newly formed bone	Histological analysis (Core biopsy) Percentage of newly formed bone after 6 months