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ClinicalTrials.gov ID

NCT05938114

Lead Sponsor

University of Central LancashireOTHER

Overall Status

Unknown status

Study Type

Interventional

Phase

Not Applicable

Enrollment

34Estimated

Last Update Posted

Nov 30, 2023Actual

Start Date

Jan 2024Estimated

Primary Completion Date

Jul 2024Estimated

Completion Date

Jul 2024Estimated

Official Title

Effectiveness of Two Bone Substitutes, Natural and Synthetic, in Preserving the Alveolar Ridge of Single-rooted Teeth: a Pilot Single-blind, Parallel Randomised Controlled Trial

Brief Summary

The goal of this clinical trial is to compare the effectiveness of a natural and synthetic bone substitute in preserving the alveolar ridge (bone) of a single- rooted tooth after an extraction.

The main question it aims to answer:

Is there a difference between natural (Bio-Oss®) and synthetic (Bonalive®) bone substitutes in preserving the alveolar ridge dimensions based on changes in the width of the alveolar ridge (expressed in millimetres) from augmentation (baseline) to 24-week follow-up (post augmentation)?

Participants will have a tooth extraction and a bone substitute will be inserted into their socket immediately after. Participants will be divided into two equal groups and those in group A will receive Bio-Oss® while those in group B will receive Bonalive®. In both groups measurements of the alveolar bone will be taken when the bone substitute is inserted and 24 weeks after the insertion of the bone substitute. These measurements will be used to compare the effectiveness of Bio-Oss® and Bonalive in preserving the alveolar bone of a tooth after an extraction.

Detailed Description

It is a pilot single-blind two-arm parallel randomised control trial that aims to assess the differences between two bone substitutes, natural versus synthetic. The study will mimic the routine practice, and patients will be randomly allocated to receive either natural (control) or synthetic (intervention) bone substitutes. The patient follow-up period will be 24 weeks from the baseline data collection point.

The University of Central Lancashire will lead the study in collaboration with Imperial College London and dental clinics in Midlands, Southeast and Northwest England. We will recruit 34 patients who require tooth extractions and divide them into two equal groups. Patients in group A will receive Bio-Oss® , while those in group B will receive Bonalive® For both groups, the bone substitute will be inserted immediately after an extraction, and the socket will be sealed with a membrane sutured in place. Patients in both groups will be reviewed after 2 weeks to remove the suture. Patients will have another review at 24 weeks, during which the researcher will take a scan or mould, a photograph, and a small biopsy sample of the area where the bone substitute was placed. Measurements obtained at the 24-week follow-up will be used to evaluate the effectiveness and differences between natural and synthetic bone substitutes in preserving the bone supporting a tooth after an extraction.

The results of this pilot study will inform the design and implementation of a full-scale randomised controlled trial to investigate the effectiveness of bioactive glass-derived bone compared with bovine-derived bone in preserving the alveolar bone of a tooth after an extraction

• Alveolar Ridge Augmentation

• Bonalive
• Bio-Oss®

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

Yes

Eligibility Criteria

Inclusion Criteria:

• Adult patients (age >18) in need of extraction of a single-rooted tooth attending the clinics selected for the study
• Single units in a dentate patient
• Non-surgical extraction - no flap raised, and no bone removed Intact socket walls post-extraction
• Bleeding sockets
• Stable periodontal health

Exclusion Criteria:

• Multiple adjacent extractions
• Presence of active periodontal disease
• Socket walls not intact - >50% bone loss in any of the four walls
• Sclerotic sockets post-extraction - the socket does not fill up with blood post-extraction
• Denture wearer - the extraction socket site under the load of a denture
• Patients on medication that can affect bone healing e.g., bisphosphonates (oral or intravenous), selective serotonin reuptake inhibitors (SSRI), methotrexate, proton pump inhibitors (PPI)
• Uncontrolled diabetes Smokers Immunosuppressed Patients
• Patients with a history of myocardial Infarction in the last year ASA Class > II patients

Primary Purpose

Supportive Care

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Single

Lead Sponsor

University of Central LancashireOTHER

Collaborators

Imperial College LondonOTHER

julian.r.jones@imperial.ac.uk

fnbarrak@uclan.ac.uk+441772201201 ext. 5911