Demineralized Whole-tooth vs Demineralized Particulate Dentin Grafts in Alveolar Ridge Preservation

Alveolar Bone Loss Clinical Trial

Official title:

Demineralized Whole-tooth vs Demineralized Particulate Dentin Grafts in Alveolar Ridge Preservation. a Randomized Controlled Trial.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05336149
• Other study ID #: 42022
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2022
• Est. completion date: June 2023

Study information

• Verified date: April 2022
• Source: Cairo University
• Contact: Ahmed Elfana, MSc
• Phone: +2223634965
• Email: ahmed.abdelraouf[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this trial is to compare whole-tooth vs particulate dentin for their effects in alveolar ridge preservation.

Description:

Extraction of the teeth is still one of the most commonly undertaken procedures in dental practices due to various reasons that render the teeth non-restorable. Following extraction, replacing the lost teeth with a prosthetic alternative that provides for both optimal esthetics and function can be challenging due to the inevitable events of socket healing that results in the reduction in alveolar bone height and width. To overcome these limitations and provide for adequate ridge volume, different bone preservation or augmentation techniques can be utilized with different clinical applications.

Alveolar ridge preservation is a procedure that attempts to reduce bone dimensional changes that naturally take place following tooth extraction. To overcome this problem, various approaches using various grafting materials and/or covering membranes have been proposed with varied success. The extracted tooth is no longer considered as clinical waste, it has been explored as an appropriate source for autogenous graft substitute. This idea emerged due to the shared embryonic origin of bone and teeth as well as the similarities in chemical structure as dentin is composed of 30-35% organic part and 65-70% inorganic part in comparison to alveolar bone, with inorganic and organic parts of 35% and 65% respectively. Both whole-tooth and particulate forms has been utilized for alveolar ridge preservation or augmentation but the superiority of one form over the other is not yet clear.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: June 2023
• Est. primary completion date: January 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Non-restorable tooth indicated for extraction

• single-rooted teeth

• Patients at least 18 years or older

• Motivated patients, agree to sign informed consent and complete the follow-up period

Exclusion Criteria:

• Pregnant females

• active infection at extraction site

• Smokers

• systemic conditions affecting healing (e.g. diabetes, medications as bisphosphonates...)

Related Conditions & MeSH terms

• Alveolar Bone Loss

Intervention

Procedure:
• Alveolar ridge preservation using whole-tooth dentin graft
Minimally-traumatic extraction of non-restorable teeth then grafting with whole-tooth dentin graft
• Alveolar ridge preservation using particulate dentin graft
Minimally-traumatic extraction of non-restorable teeth then grafting with particulate dentin graft

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alveolar bone width change in mm	Alveolar bone linear width will be measured at baseline at final cone beam computed tomography (CBCT) scans. The change in bone width will be calculated as the subtraction of final width from baseline width and will be expressed in millimetres.	6 months
Secondary	Alveolar bone height change in mm	Alveolar bone linear height will be measured at baseline at final cone beam computed tomography (CBCT) scans. The change in bone height will be calculated as the subtraction of final height from baseline height and will be expressed in millimetres.	6 months
Secondary	Histological assessment	Bone samples from at least one control and one intervention site will be taken during implant placement using a trephine bur. Samples will be examined for new bone formation (Yes/no) and inflammatory response (Yes/no).	6 months