Clinical trial NCT05938114: Comparison of the Use of Natural and Synthetic Bone Substitutes in Dental Implants
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Alveolar Ridge Augmentation
Keywords: Ridge Preservation
Bone Substitutes
Alveolar Bone
Lead sponsor: University of Central Lancashire
Sponsor class: OTHER
Collaborators: name: Imperial College London
First posted: 2023-07-10
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

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 outcomes:
measure: Primary outcome measure is the change in the width of the alveolar ridge
timeFrame: Outcome data will be collected at baseline and week 24
Secondary outcomes:
measure: Change in height of the alveolar bone.
timeFrame: This outcome data will be collected at baseline and at week 24
measure: Changes in the vertical crestal bone level
timeFrame: This outcome data will be collected at baseline and at week 24
measure: Presence of bone around the alveolar ridge Concentration (in nanograms) of gene expression for bone markers
timeFrame: Outcome data will be obtained at week 24
Other outcomes:
Locations:
city: Preston
country: United Kingdom
facility: University of Central Lanchashire
state: Lancashire
city: Cambridge
country: United Kingdom
facility: Devonshire House Dental Practice
city: East Grinstead
country: United Kingdom
facility: St Faith's Dental Clinic,
city: Halesowen
country: United Kingdom
facility: Halesowen Dental
city: London
country: United Kingdom
facility: Imperical College,London
city: Preston
country: United Kingdom
facility: UCLan community Dentists
Study officials:
affiliation: University of Central Lancashire
name: Ihtesham Rehman, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.