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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Alveolar Ridge Augmentation
- Sponsor
- University of Central Lancashire
- Enrollment
- 34
- Locations
- 6
- Primary Endpoint
- Primary outcome measure is the change in the width of the alveolar ridge
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
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
Investigators
Fadi Barrak
Course Lead and Senior Lecturer, University of Central Lancashire, School of Dentistry
University of Central Lancashire
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
Outcomes
Primary Outcomes
Primary outcome measure is the change in the width of the alveolar ridge
Time Frame: Outcome data will be collected at baseline and week 24
The change in the width of the alveolar ridge is expressed in millimetres and it will be obtained using intra-oral scanners (this does not involve radiographs) or impressions and clinical photographs.
Secondary Outcomes
- Change in height of the alveolar bone.(This outcome data will be collected at baseline and at week 24)
- Presence of bone around the alveolar ridge Concentration (in nanograms) of gene expression for bone markers(Outcome data will be obtained at week 24)
- Changes in the vertical crestal bone level(This outcome data will be collected at baseline and at week 24)