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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Alveolar Bone Loss
• Intervention / Treatment: Procedure: Alveolar ridge preservation using whole-tooth dentin graft; Procedure: Alveolar ridge preservation using particulate dentin graft

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed Elfana, MSc; Phone Number: +2223634965; Email: ahmed.abdelraouf@dentistry.cu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt
    • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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...)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Whole-tooth dentin graft; The extracted tooth will be prepared as whole-tooth dentin graft and inserted in the extraction socket.	Procedure: Alveolar ridge preservation using whole-tooth dentin graft; Minimally-traumatic extraction of non-restorable teeth then grafting with whole-tooth dentin graft
Active Comparator: Particulate dentin graft; The extracted tooth will be prepared as particulate dentin graft and inserted in the extraction socket.	Procedure: Alveolar ridge preservation using particulate dentin graft; Minimally-traumatic extraction of non-restorable teeth then grafting with particulate dentin graft

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2022
• Primary Completion (Anticipated): January 1, 2023
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: April 4, 2022
• First Submitted That Met QC Criteria: April 15, 2022
• First Posted (Actual): April 20, 2022

Study Record Updates

• Last Update Posted (Actual): April 20, 2022
• Last Update Submitted That Met QC Criteria: April 15, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Bone Diseases; Periodontal Atrophy; Bone Resorption; Alveolar Bone Loss
• Other Study ID Numbers: 42022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No