MedDataX Logo

Histologic Comparison of Healing After Tooth Extraction With Ridge Preservation Using Two Different Xenografts

NCT ID: NCT03769376

Last Updated: 2021-12-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-22

Study Completion Date

2021-03-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to compare the speed of bone healing of the two most commonly used xenografts on the market, Bio-Oss® and Salvin-Oss® using a tooth extraction ridge preservation model in participants scheduled for tooth extraction and subsequent receipt of a dental implant. Researchers hypothesize that there will be additional vital bone at 16-20 weeks with Salvin-Oss®.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This study focuses on xenografts to preserve alveolar bone after tooth extraction prior to placement of a dental implant. Extraction sites that are not grafted for ridge preservation may lose up to 50 percent of their ridge width the first year after extraction. Xenografts are one of several products on the market used to maintain ridge width after tooth extraction. This study aims to compare the two most commonly used, FDA-approved xenografts on the market, Bio-Oss® and Salvin-Oss, in the preservation of alveolar bone after extraction of non-molar teeth.

The primary objective of this study is to histologically evaluate and compare the percentage of new bone formation in healing extraction sockets of non-molar teeth grafted with Bio-Oss® versus Salvin-Oss®. The secondary aim is to observe clinical changes in ridge height and ridge width after grafting with these two materials.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Partial Edentulism

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

toothlessness

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients will be randomly assigned (1:1) to one of two treatment groups (Bio-Oss® or Salvin-Oss®) at the time of surgery through random selection of sealed envelopes.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Participants will be randomly assigned (1:1) to one of two treatment groups (Bio-Oss® or Salvin-Oss®) at the time of surgery through random selection of sealed envelopes. The outcome assessor for histological samples will not be aware of which group the participant was in until code unlocked.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Bio-Oss®

Bio-Oss® xenograft bone material will be placed into the socket following tooth extraction. Half of participants will be randomly assigned to this treatment group (1:1).

Group Type ACTIVE_COMPARATOR

Bio-Oss®

Intervention Type DEVICE

Bio-Oss® xenograft bone material will be placed into the socket following tooth extraction.

Salvin-Oss®

Salvin-Oss® xenograft bone material will be placed into the socket following tooth extraction. Half of participants will be randomly assigned to this treatment group (1:1).

Group Type ACTIVE_COMPARATOR

Salvin-Oss®

Intervention Type DEVICE

Salvin-Oss® xenograft bone material will be placed into the socket following tooth extraction.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Bio-Oss®

Bio-Oss® xenograft bone material will be placed into the socket following tooth extraction.

Intervention Type DEVICE

Salvin-Oss®

Salvin-Oss® xenograft bone material will be placed into the socket following tooth extraction.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* At least 18 years of age.
* Consent to be in the study.
* Planned for non-emergent dental treatment.
* American Society of Anesthesiologist Class I or II.
* Require extraction of a single-rooted non-molar tooth.
* Committed to have the dental implant placed at the site of extraction 16-20 weeks after extraction and ridge preservation.
* Adequate restorative space for implant-retained restoration.
* \> 10mm alveolar bone height without impingement on the maxillary sinus or inferior alveolar canal.
* Root location and angulation that would be consistent with the subsequent implant placement.
* Roots with minimum of 10mm of radiographic bone support.
* Root angulation similar to the angulation of the implant to be placed at the site.

Exclusion Criteria

* \< 18 years old.
* Currently pregnant.
* Require antibiotic prophylaxis prior to dental procedures as outlined by the 2017 American Heart Association guidelines.
* Decisionally challenged individuals.
* Current smokers.
* American Society of Anesthesiologist Class III or IV.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kerri Font, DDS, MS

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Charles A Powell, DDS, MS

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Colorado School of Dental Medicine

Aurora, Colorado, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

18-1722

Identifier Type: -

Identifier Source: org_study_id