Comparison of the Use of Natural and Synthetic Bone Substitutes in Dental Implants

NCT05938114 | Unknown DMC

• 2 other identifiers: HEALTH 01032IRAS ID: 316275
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 6

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.

Conditions

Alveolar Ridge Augmentation

Keywords

Ridge Preservation; Bone Substitutes; Alveolar Bone

Outcome Measures

Primary Outcomes (1)

• Primary outcome measure is the change in the width of the alveolar ridge

  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.

  Outcome data will be collected at baseline and week 24

Secondary Outcomes (3)

• Change in height of the alveolar bone.

  This outcome data will be collected at baseline and at week 24

• Changes in the vertical crestal bone level

  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

Study Arms (2)

Group A (Bonalive®)

EXPERIMENTAL

The test bone substitute is Bonalive®, bioactive glass S53P4, which contains SiO2, Na2O, CaO, and P2O5 (granule size 0.5-0.8mm). Bonalive® is osteoconductive, meaning that it has the ability of promoting bone growth across the granules and the grafting area and slowly replace it with new bone over time. Bonalive® is osteostimulative and has antibacterial properties

Other: Bonalive

Group B ( Bio-Oss®)

ACTIVE COMPARATOR

The comparator is Bio-Oss®, deproteinized bovine bone granules (granule size 0.25- 1mm). Bio-Oss® is osteoconductive, which means it acts as a scaffold only for new bone to grow.

Other: Bio-Oss®

Interventions

Bonalive OTHER

Bonalive® is a bioactive glass synthetic bone substitute material that has been shown to have a low substitution rate and antibacterial properties. It has been used successfully in the orthopaedics, craniofacial and ear nose and throat (ENT) specialities for the treatment of osteomyelitis, sinusitis and bony cyst cavities. There have also been a few maxillofacial surgery case reports on its usage in the jaws.

Group A (Bonalive®)

Bio-Oss® OTHER

Bio-Oss® is a bovine xenogeneic bone graft substitute that is widely used in regenerative dentistry. Bio-Oss® is very similar to human bone in its structure and chemical make-up. The material's porosity allows for vascularisation and new bone formation.

Group B ( Bio-Oss®)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Central Lancashire: lead
• Imperial College London: collaborator

Study Sites (6)

University of Central Lanchashire

Preston, Lancashire, PR1 2HE, United Kingdom

Location

Devonshire House Dental Practice

Cambridge, CB1 7PN, United Kingdom

Location

St Faith's Dental Clinic,

East Grinstead, RH19 1PN, United Kingdom

Location

Halesowen Dental

Halesowen, B63 3NQ, United Kingdom

Location

Imperical College,London

London, SW7 2AZ, United Kingdom

Location

UCLan community Dentists

Preston, PR1 2HE, United Kingdom

Location

Related Publications (2)

• Solakoglu O, Gotz W, Heydecke G, Schwarzenbach H. Histological and immunohistochemical comparison of two different allogeneic bone grafting materials for alveolar ridge reconstruction: A prospective randomized trial in humans. Clin Implant Dent Relat Res. 2019 Oct;21(5):1002-1016. doi: 10.1111/cid.12824. Epub 2019 Aug 19.

  PMID: 31424173 BACKGROUND

• Rignon-Bret C, Hadida A, Aidan A, Nguyen TH, Pasquet G, Fron-Chabouis H, Wulfman C. Efficacy of bone substitute material in preserving volume when placing a maxillary immediate complete denture: study protocol for the PANORAMIX randomized controlled trial. Trials. 2016 May 20;17(1):255. doi: 10.1186/s13063-016-1380-7.

  PMID: 27206923 BACKGROUND

MeSH Terms

Interventions

Bio-Oss

Study Officials

• Ihtesham Rehman, PhD

  University of Central Lancashire

  STUDY CHAIR

Central Study Contacts

FADI BARRAK, MBBS; BDS

CONTACT

+441772201201; fnbarrak@uclan.ac.uk

Aderonke Ajiboye, BDS

CONTACT

07846272779; aajiboye@uclan.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Course Lead and Senior Lecturer, University of Central Lancashire, School of Dentistry

Study Record Dates

• First Submitted: June 30, 2023
• First Posted: July 10, 2023
• Study Start: January 1, 2024
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: November 30, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: According to UCLan's Research Data Management Policy, all digital research data that has been selected by the Data Steward or research group for retention should be deposited in the UCLan data repository or a suitable national or international data service or subject repository within 12 months of generation. The fully anonymised data set will be available in perpetuity to other researchers in the UCLanData OA repository under the open data policy.
• Access Criteria: When the data is deposited at the UCLanData OA repository, a digital object identifier (DOI) which is unique to the dataset and ensures it continues to be accessible will be created. The DOI for the data collected in this research will be provided in the research publication.

Locations

GB (6)