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

• Sponsor: University of Colorado, Denver (Other)
• Overall Status: Completed
• CT.gov ID: NCT03769376
• Collaborator: (none)
• Enrollment: 38
• Location: 1
• Arms: 2
• Actual Duration (Months): 21.8
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief Summary

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®.

Condition or Disease	Intervention/Treatment	Phase
Partial Edentulism	Device: Bio-Oss®; Device: Salvin-Oss®	N/A

Detailed Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 38 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 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.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.
• Masking: Single (Outcomes Assessor)
• Masking Description: 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.
• Primary Purpose: Treatment
• Official Title: Histologic Comparison of Healing After Tooth Extraction With Ridge Preservation Using Two Different Xenografts
• Actual Study Start Date: May 22, 2019
• Actual Primary Completion Date: Mar 15, 2021
• Actual Study Completion Date: Mar 15, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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).	Device: Bio-Oss®; Bio-Oss® xenograft bone material will be placed into the socket following tooth extraction.
Active Comparator: 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).	Device: Salvin-Oss®; Salvin-Oss® xenograft bone material will be placed into the socket following tooth extraction.

Outcome Measures

Primary Outcome Measures

1. New Bone Formation at Extraction/Xenograft Site Measured by Histological Evaluation at 16-20 Weeks [Baseline to 16-20 weeks]

   The amount of new bone formation at the tooth extraction/xenograft site as measured by the percent of vital bone, residual graft, and connective tissue observed in a histological sample (a bone biopsy) obtained at the time of dental implant insertion, 16-20 weeks after extraction.

2. New Bone Formation at Extraction/Xenograft Site Measured Clinically With Dental Probe at 16-20 Weeks [Baseline to 16-20 weeks]

   The boney ridge height on both the buccal/lingual and width in area of the extraction/xenograft site as measured at time of implant placement with an intra-oral dental probe at 16-20 weeks after extraction. Percent change in ridge width from baseline is reported

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Colorado School of Dental Medicine	Aurora	Colorado	United States	80045

Sponsors and Collaborators

• University of Colorado, Denver

Investigators

• Principal Investigator: Kerri Font, DDS, MS, University of Colorado, Denver
• Principal Investigator: Charles A Powell, DDS, MS, University of Colorado, Denver

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 15, 2021

More Information

Publications

None provided.

• Responsible Party: University of Colorado, Denver
• ClinicalTrials.gov Identifier: NCT03769376
• Other Study ID Numbers: 18-1722
• First Posted: Dec 7, 2018
• Last Update Posted: Dec 15, 2021
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by University of Colorado, Denver: toothlessness
• Additional relevant MeSH terms: Salvin

Study Results

Participant Flow

Arm/Group Title	Bio-Oss®	Salvin-Oss®
Arm/Group Description	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). Bio-Oss®: Bio-Oss® xenograft bone material will be placed into the socket following tooth extraction.	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). Salvin-Oss®: Salvin-Oss® xenograft bone material will be placed into the socket following tooth extraction.
Period Title: Overall Study
STARTED	20	18
COMPLETED	13	11
NOT COMPLETED	7	7

Baseline Characteristics

Arm/Group Title	Bio-Oss®	Salvin-Oss®	Total
Arm/Group Description	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). Bio-Oss®: Bio-Oss® xenograft bone material will be placed into the socket following tooth extraction.	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). Salvin-Oss®: Salvin-Oss® xenograft bone material will be placed into the socket following tooth extraction.	Total of all reporting groups
Overall Participants	20	18	38
Age, Customized (Count of Participants)
<18 years	0 0%	0 0%	0 0%
Between 18 and 100 years	20 100%	18 100%	38 100%
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	0 0%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
United States	20 100%	18 100%	38 100%

Outcome Measures

1. Primary Outcome

Title	New Bone Formation at Extraction/Xenograft Site Measured by Histological Evaluation at 16-20 Weeks
Description	The amount of new bone formation at the tooth extraction/xenograft site as measured by the percent of vital bone, residual graft, and connective tissue observed in a histological sample (a bone biopsy) obtained at the time of dental implant insertion, 16-20 weeks after extraction.
Time Frame	Baseline to 16-20 weeks

Outcome Measure Data

Analysis Population Description

Only participants that completed the study are included in the analysis.

Arm/Group Title	Bio-Oss®	Salvin-Oss®
Arm/Group Description	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). Bio-Oss®: Bio-Oss® xenograft bone material will be placed into the socket following tooth extraction.	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). Salvin-Oss®: Salvin-Oss® xenograft bone material will be placed into the socket following tooth extraction.
Measure Participants	13	11
Vital bone	29.38	32.05
Residual graft	14.02	16.56
Connective Tissue/other	56.61	51.39

2. Primary Outcome

Title	New Bone Formation at Extraction/Xenograft Site Measured Clinically With Dental Probe at 16-20 Weeks
Description	The boney ridge height on both the buccal/lingual and width in area of the extraction/xenograft site as measured at time of implant placement with an intra-oral dental probe at 16-20 weeks after extraction. Percent change in ridge width from baseline is reported
Time Frame	Baseline to 16-20 weeks

Outcome Measure Data

Analysis Population Description

Only participants that completed the study are included in the analysis.

Arm/Group Title	Bio-Oss®	Salvin-Oss®
Arm/Group Description	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). Bio-Oss®: Bio-Oss® xenograft bone material will be placed into the socket following tooth extraction.	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). Salvin-Oss®: Salvin-Oss® xenograft bone material will be placed into the socket following tooth extraction.
Measure Participants	13	11
Mean (Full Range) [Percent]	15.38	9.09

Adverse Events

Time Frame	20 Weeks
Arm/Group Title	Bio-Oss®		Salvin-Oss®
Arm/Group Description	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). Bio-Oss®: Bio-Oss® xenograft bone material will be placed into the socket following tooth extraction.		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). Salvin-Oss®: Salvin-Oss® xenograft bone material will be placed into the socket following tooth extraction.
All Cause Mortality
	Bio-Oss®		Salvin-Oss®
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/18 (0%)
Serious Adverse Events
	Bio-Oss®		Salvin-Oss®
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/18 (0%)
Other (Not Including Serious) Adverse Events
	Bio-Oss®		Salvin-Oss®
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/18 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.