Biomaterials Exposed to Oral Environment: Which One is the Appropriate Option?

NCT07589751 | Enrolling By Invitation

• 2 other identifiers: CAAE 92555525.3.0000.5336MTA 24-209
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

After tooth extraction, bone loss can compromise future dental implant treatment. Dentists often use biomaterials to preserve bone, but in many cases these materials are left exposed to the oral environment, where saliva and bacteria may affect healing. This study will investigate how different collagen-based biomaterials behave when exposed in the mouth, evaluating healing, bone changes, bacterial contamination, and patient experience. Sixty patients will be included in a randomized clinical trial comparing two commonly used biomaterials and natural healing. The results will help clinicians choose safer and more effective treatments, improving outcomes for patients undergoing tooth extraction and future implant rehabilitation.

Conditions

Tooth Extraction Site Healing; Alveolar Ridge Preservation

Keywords

alveolar preservation; bone regeneration; biomaterials

Outcome Measures

Primary Outcomes (1)

• Alveolar dimension changes (millimetres)

  To compare the alveolar dimensions (vertically and horizontally) in millimetres of two different approaches using biomaterials (collagen membrane vs. collagen matrix) when intentionally exposed to the oral environment after an alveolar preservation procedure without primary closure, and a negative control without alveolar preservation. These measures will be done using periodontal probes by a trained and calibrated evaluator.

  From the surgery to the last follow-up at 3 months

Secondary Outcomes (3)

• Biomaterial contamination (colony count - bacterial colony number)

  Immediately after surgery to 21 days of follow-up

• Radiographic alveolar bone dimensions (vertical and horizontal measures) in millimetres

  From the surgery to the last follow-up at 3 months

• Patient-related outcomes (OHIP-49 and VAS questionnaires) - score

  From the surgery to the last follow-up at 3 months.

Study Arms (3)

Negative control group

NO INTERVENTION

A negative control group will be applied without any type of alveolar preservation, only minimally invasive extraction.

Group test 1

EXPERIMENTAL

Alveolar ridge preservation (ARP) using Bio-Oss Collagen® + Bio-Gide® exposed to the oral environment.

Procedure: Alveolar Ridge Reconstruction

Group test 2

EXPERIMENTAL

Alveolar ridge preservation using Bio-Oss Collagen® + Mucograft® Seal® exposed to the oral environment.

Procedure: Alveolar Ridge Reconstruction

Interventions

Alveolar Ridge Reconstruction PROCEDURE

Alveolar ridge preservation (ARP) using Bio-Oss Collagen® + Bio-Gide® exposed to the oral environment.

Group test 1

Eligibility Criteria

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

You may qualify if:

• Adult subjects in need of non-molar maxillary or mandibular single tooth extraction at the PUCRS university - Porto Alegre - Brazil.
• \> 18 years of age
• non-molar tooth indicated for extraction
• intact sockets upon extractions
• Patients using removable provisional prosthesis (accessible to remove possible contact with surgical site) or patients without prosthesis after tooth extraction.

You may not qualify if:

• Current smokers
• Uncontrolled Diabetes Mellitus
• Mandibular incisors
• Patients receiving chemo or radiotherapy or history of these treatments in the previous 5 years
• Any other disease or medications that may compromise normal wound healing
• Unwilling or unable to sing the informed consent

Sponsors & Collaborators

• Pontificia Universidade Católica do Rio Grande do Sul: lead
• Geistlich Pharma AG: collaborator

Study Sites (1)

PUCRS

Porto Alegre, Rio Grande do Sul, 90619900, Brazil

Location

Related Publications (5)

• Barootchi S, Tavelli L, Majzoub J, Stefanini M, Wang HL, Avila-Ortiz G. Alveolar ridge preservation: Complications and cost-effectiveness. Periodontol 2000. 2023 Jun;92(1):235-262. doi: 10.1111/prd.12469. Epub 2022 Dec 29.

  PMID: 36580417 BACKGROUND

• Kunrath MF, Dahlin C. The Impact of Early Saliva Interaction on Dental Implants and Biomaterials for Oral Regeneration: An Overview. Int J Mol Sci. 2022 Feb 11;23(4):2024. doi: 10.3390/ijms23042024.

  PMID: 35216139 BACKGROUND

• Couso-Queiruga E, Weber HA, Garaicoa-Pazmino C, Barwacz C, Kalleme M, Galindo-Moreno P, Avila-Ortiz G. Influence of healing time on the outcomes of alveolar ridge preservation using a collagenated bovine bone xenograft: A randomized clinical trial. J Clin Periodontol. 2023 Feb;50(2):132-146. doi: 10.1111/jcpe.13744. Epub 2022 Nov 18.

  PMID: 36345818 BACKGROUND

• Kunrath MF, Giraldo-Osorno PM, Mendes K, Gomes ATPC, Rosa N, Barros M, Dahlin C. Unveiling the consequences of early human saliva contamination on membranes for guided bone regeneration. J Periodontal Res. 2024 Dec;59(6):1196-1209. doi: 10.1111/jre.13266. Epub 2024 Apr 22.

  PMID: 38644743 BACKGROUND

• Buser D, Urban I, Monje A, Kunrath MF, Dahlin C. Guided bone regeneration in implant dentistry: Basic principle, progress over 35 years, and recent research activities. Periodontol 2000. 2023 Oct;93(1):9-25. doi: 10.1111/prd.12539.

  PMID: 38194351 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: May 15, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: May 15, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF

Locations

BR (1)