An interventional study of Alveolar Ridge Reconstruction and Alveolar Ridge Reconstruction in Tooth Extraction Site Healing and Alveolar Ridge Preservation, sponsored by Pontificia Universidade Católica do Rio Grande do Sul. Enrolling by invitation at 1 site in Brazil. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by Pontificia Universidade Católica do Rio Grande do Sul · Not applicable, Interventional, and Treatment
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.
Surgical procedures and group division Following patient selection, minimal invasive extractions will be performed and standard alveolar preservation will be done using Bio-oss Collagen® - Geistlich for alveolar filling and (BioGide® or Mucograft® Seal - Geistlich, depending on the study group) for covering the gap-filling procedure showing one biomaterial side exposed to the oral cavity environment. The patients will be divided randomly into three experimental groups of 20 patients each, completing 60 patients. One group will receive alveolar preservation with Bio-oss Collagen® + BioGide® and the other group will receive alveolar preservation with Bio-oss Collagen® + Mucograft® Seal. A negative control group will be applied without any type of alveolar preservation, only minimally invasive extraction.
Evaluation time points will be named T0, T1, T2, T3 (T0 = immediate after surgery, T1 = 1 week, T2 = 3 weeks, T3 = 3 months).
After surgeries, patients will receive detailed verbal and written post-operative instructions, prescriptions for anti-inflammatory medication (ibuprofen 600 mg for 3 days, if needed), and antibiotic therapy (amoxicillin 500 mg every 8h for 7 days or, in case of penicillin allergy, clindamycin 300 mg every 6h for 7 days). Patients will be recalled at 1 (T1), 3 weeks (T2), and after three months (T3). Sutures were removed at 1 week. Patients will be advised to not use mouth rinses in order to not compromise the surgical procedure. Normal hygiene using toothbrushes and toothpastes will be indicated to the patients to maintain clean conditions.
Following surgical procedures, the surgical sites will be evaluated regarding biomaterial contamination, clinical tissue healing, and radiographic conditions.
Biomaterial surface contamination For biomaterial contamination, a sterilized swab for bacterial analysis will be used directly over the procedure (per patient/per time) for investigation of potential biomaterial surface contamination at T0, T1, and T2. Following this, the bacterial collection will be processed and evaluated at the Microbiological laboratory. The potential bacterial collection will be spread in agar plates and cultured in a stove under appropriate bacteria conditions for 24 hours. Bacteria colonies will be evaluated and counted comparing the proposed groups and time points in this study.
A control collection will be performed before the surgical procedure in the tooth extraction region using a sterilized swab to evaluate the previous microbiome and similarities to the post-surgery evaluations.
Adult subjects in need of non-molar maxillary or mandibular single tooth extraction at the PUCRS university - Porto Alegre - Brazil.
Exclusion Criteria:
A negative control group will be applied without any type of alveolar preservation, only minimally invasive extraction.
Alveolar ridge preservation (ARP) using Bio-Oss Collagen® + Bio-Gide® exposed to the oral environment.
Procedure: Alveolar Ridge Reconstruction
Alveolar ridge preservation using Bio-Oss Collagen® + Mucograft® Seal® exposed to the oral environment.
Procedure: Alveolar Ridge Reconstruction
Alveolar ridge preservation (ARP) using Bio-Oss Collagen® + Bio-Gide® exposed to the oral environment.
ARP using Bio-Oss Collagen® + Mucograft® Seal® exposed to the oral environment.
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.
Time frame: From the surgery to the last follow-up at 3 months
Biomaterial contamination (colony count - bacterial colony number)
To compare the number of colonies formed after contamination collection with swabs on the surfaces of two different biomaterials (collagen membrane vs collagen matrix) when intentionally exposed to the oral environment following an alveolar preservation procedure without primary closure. The number of colonies will be counted with a microscope and tabulated in accordance with microbiological standards.
Time frame: Immediately after surgery to 21 days of follow-up
Radiographic alveolar bone dimensions (vertical and horizontal measures) in millimetres
A radiographic comparison of the alveolar dimension changes between the three groups will be done using digital periapical radiographs and a digital ruler in the radiographic software to measure the alveolar dimensions (vertically and horizontally) in millimetres after the surgical procedures.
Time frame: From the surgery to the last follow-up at 3 months
Patient-related outcomes (OHIP-49 and VAS questionnaires) - score
To investigate the quality of life measurements using the OHIP-49 questionnaire and to measure pain using the VAS scale questionnaire after the surgical interventions. These questionnaires have a scale pointing 1 to 5, which generates a score for each question. Therefore, the measure will be a final score at each time point.
Time frame: From the surgery to the last follow-up at 3 months.
Plan to share: Yes
Supporting information: Sap, Icf
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Pontificia Universidade Católica do Rio Grande do Sul