Alveolar Ridge Preservation With Putty Allograft vs. Putty Alloplast Graft

NCT05484492 | Completed Phase 4 FDA Drug

• 1 other identifier: 22.0560
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aims of this study are to compare, after 4 months, the clinical and histologic results of a combination demineralized/mineralized putty allograft vs. synthetic calcium phosphosilicate (CPS) putty alloplast graft utilization in socket preservation procedures. A regenerative tissue matrix membrane will be used to cover each graft lying below the flap.

Conditions

Alveolar Bone Resorption

Keywords

Alveolar ridge preservation; Socket preservation

Outcome Measures

Primary Outcomes (3)

• Alveolar ridge width

  Alveolar ridge width (measured in mm) after 4 months of healing

  4 months

• Alveolar ridge height

  Alveolar ridge height (measured in mm) after 4 months of healing

  4 months

• Buccal soft tissue thickness

  Buccal soft tissue thickness at crest of alveolar ridge (measured in mm)

  4 months

Secondary Outcomes (1)

• Percentage of vital bone present

  4 months

Study Arms (2)

demineralized and mineralized combination putty bone allograft

EXPERIMENTAL

Fifteen test patients will receive an intrasocket demineralized and mineralized combination putty allograft (MinerOss Putty, BioHorizons) with a regenerative tissue matrix membrane (AlloDerm GBR, BioHorizons) following tooth extraction.

Biological: demineralized and mineralized combination putty bone allograft

calcium phosphosilicate putty alloplast graft

ACTIVE COMPARATOR

The positive control group of fifteen patients will receive an intrasocket synthetic resorbable calcium phosphosilicate putty alloplast graft (NovaBone, Osteogenics) covered with a regenerative tissue matrix membrane (AlloDerm GBR, BioHorizons) following tooth extraction.

Biological: calcium phosphosilicate putty alloplast graft

Interventions

calcium phosphosilicate putty alloplast graft BIOLOGICAL

Subjects in this group will receive an intrasocket synthetic resorbable calcium phosphosilicate putty alloplast graft following tooth extraction

Also known as: NovaBone, Osteogenics

calcium phosphosilicate putty alloplast graft

demineralized and mineralized combination putty bone allograft BIOLOGICAL

Subjects in this group will receive an intrasocket demineralized and mineralized combination putty bone allograft following tooth extraction

Also known as: MinerOss Putty, BioHorizons

demineralized and mineralized combination putty bone allograft

Eligibility Criteria

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

You may qualify if:

• Have one non-molar tooth requiring extraction that will be replaced by a dental implant.
• The site must be bordered by at least one tooth.
• Healthy male or female who is at least 18 years old.
• Patients must sign an informed consent approved by the University of Louisville Human Studies Committee.

You may not qualify if:

• Patients with debilitating systemic diseases, or diseases that have a clinically significant effect on the periodontium.
• Presence or history of osteonecrosis of jaws.
• Patients who are currently taking IV bisphosphonates or who had IV treatment with bisphosphonates irrespective of duration.
• Patients who have been treated with oral bisphosphonates for more than three years.
• Patients with an allergy to any material or medication used in the study.
• Patients who need prophylactic antibiotics
• Previous head and neck radiation therapy.
• Chemotherapy in the previous 12 months.
• Patients on long term NSAID or steroid therapy.
• Pregnant patients.

Sponsors & Collaborators

• University of Louisville: lead
• BioHorizons, Inc.: collaborator

Study Sites (1)

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Related Publications (9)

• Araujo MG, Lindhe J. Dimensional ridge alterations following tooth extraction. An experimental study in the dog. J Clin Periodontol. 2005 Feb;32(2):212-8. doi: 10.1111/j.1600-051X.2005.00642.x.

  PMID: 15691354 BACKGROUND

• Araujo MG, da Silva JCC, de Mendonca AF, Lindhe J. Ridge alterations following grafting of fresh extraction sockets in man. A randomized clinical trial. Clin Oral Implants Res. 2015 Apr;26(4):407-412. doi: 10.1111/clr.12366. Epub 2014 Mar 12.

  PMID: 24621203 BACKGROUND

• Barone A, Ricci M, Tonelli P, Santini S, Covani U. Tissue changes of extraction sockets in humans: a comparison of spontaneous healing vs. ridge preservation with secondary soft tissue healing. Clin Oral Implants Res. 2013 Nov;24(11):1231-7. doi: 10.1111/j.1600-0501.2012.02535.x. Epub 2012 Jul 12.

  PMID: 22784417 BACKGROUND

• Jung RE, Philipp A, Annen BM, Signorelli L, Thoma DS, Hammerle CH, Attin T, Schmidlin P. Radiographic evaluation of different techniques for ridge preservation after tooth extraction: a randomized controlled clinical trial. J Clin Periodontol. 2013 Jan;40(1):90-8. doi: 10.1111/jcpe.12027. Epub 2012 Nov 19.

  PMID: 23163915 BACKGROUND

• Laster L, Laudenbach KW, Stoller NH. An evaluation of clinical tooth mobility measurements. J Periodontol. 1975 Oct;46(10):603-7. doi: 10.1902/jop.1975.46.10.603.

  PMID: 1058939 BACKGROUND

• Leblebicioglu B, Salas M, Ort Y, Johnson A, Yildiz VO, Kim DG, Agarwal S, Tatakis DN. Determinants of alveolar ridge preservation differ by anatomic location. J Clin Periodontol. 2013 Apr;40(4):387-95. doi: 10.1111/jcpe.12065. Epub 2013 Feb 21.

  PMID: 23432761 BACKGROUND

• Llanos AH, Sapata VM, Jung RE, Hammerle CH, Thoma DS, Cesar Neto JB, Pannuti CM, Romito GA. Comparison between two bone substitutes for alveolar ridge preservation after tooth extraction: Cone-beam computed tomography results of a non-inferiority randomized controlled trial. J Clin Periodontol. 2019 Mar;46(3):373-381. doi: 10.1111/jcpe.13079. Epub 2019 Mar 3.

  PMID: 30710389 BACKGROUND

• O'Leary TJ, Drake RB, Naylor JE. The plaque control record. J Periodontol. 1972 Jan;43(1):38. doi: 10.1902/jop.1972.43.1.38. No abstract available.

  PMID: 4500182 BACKGROUND

• Lobene RR, Weatherford T, Ross NM, Lamm RA, Menaker L. A modified gingival index for use in clinical trials. Clin Prev Dent. 1986 Jan-Feb;8(1):3-6. No abstract available.

  PMID: 3485495 BACKGROUND

MeSH Terms

Interventions

Bioglass

Study Officials

• Bindu Dukka, BDS,MSD,MPH

  Director, Graduate Periodontics, University of Louisville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study involves an investigator (surgeon) and an examiner. The examiner measures the clinical parameters before and after surgery and is blinded to the surgical procedure and type of graft the patient receives.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Graduate Periodontics

Model Details: Thirty patients will be treated using the principles of guided bone regeneration utilizing a full thickness flap for ridge preservation. Fifteen test patients will receive an intrasocket demineralized and mineralized combination putty allograft with a regenerative tissue matrix membrane. The positive control group of fifteen patients will receive an intrasocket synthetic resorbable calcium phosphosilicate putty alloplast graft covered with a regenerative tissue matrix membrane. Approximately four months post-surgery, a trephine core will be taken from the grafted site immediately prior to implant placement and submitted for histologic processing.

Study Record Dates

• First Submitted: July 6, 2022
• First Posted: August 2, 2022
• Study Start: October 6, 2022
• Primary Completion: October 7, 2025
• Study Completion: October 30, 2025
• Last Updated: February 10, 2026

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)