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

9. maj 2026 opdateret af: Marcel Ferreira Kunrath, Pontificia Universidade Católica do Rio Grande do Sul
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.

Studieoversigt

Status

Tilmelding efter invitation

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

  1. Ethical considerations and patient selection This study will be previously submitted to the ethical committee of PUCRS - Brazil for appreciation and evaluation following the international ethical guidelines for clinical studies. Following ethical acceptance, patients needing non-molar tooth extraction with four/three walls of alveolar integrity will be selected for this study. Exclusion and inclusion criteria will be applied in the patient's selection according to potential systemic diseases and external habits that influence bone regeneration. (please, check inclusion and exclusion criteria).

  2. 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.

  3. 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.

  4. Radiographic evaluation For radiographic investigation, digital periapical radiographs will be performed on pre-operatory days (for diagnostics of tooth extraction); at T1 and T3, evaluating potential procedure failures or infiltration by comparing the time points. Measurements will be performed digitally using the radiographic software associated with the X-ray to investigate regenerated bone and possible bacterial infiltration comparing the groups.
  5. Qualitative and quantitative clinical outcomes Early clinical healing will be evaluated at three different times (T0, T1, T2, T3) through clinical observation and alveolar measurements using a periodontal probe in millimeters. Linear alveolar size and soft tissue contour measurements will be evaluated using a periodontal probe (measuring the mesio-distal and buccal-lingual/palatal distance in millimeters) according to the alveolo size and possible alveolo changes, directly after tooth extraction, at T0, T1, T2, and T3. Additionally, qualitative photographs will be performed for evaluation of early tissue healing, possible infection, possible failures, and/or dehiscence.
  6. Patient-reported outcome measures Patients will be asked to rate their level of post-operative discomfort and overall satisfaction after alveolar ridge preservation at T0, T1, T2 and T3. The questionnaire will be applied using a simple table with a 100-point visual analogue scale where the patient will be able to select from 0 to 100 (0 for worst evaluation and 100 for the higher evaluation). (Couso-Queiruga et al. Influence of healing time on the outcomes of alveolar ridge preservation using a collagenated bovine bone xenograft: a randomized clinical trial. Journal of clinical periodontology, 50(2), 132-146, 2023).
  7. Statistical analysis The data will be analyzed using one-way ANOVA, followed by post hoc testing Tukey HSD test if necessary, comparing the three experimental groups in the three different time points. Bacterial assays will be performed in triplicate for each time point. A significant variation between groups was considered to occur at 5% (p < 0.05).

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Brasilien
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brasilien, 90619900
        • PUCRS

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Beskrivelse

Inclusion Criteria:

  • Adult subjects in need of non-molar maxillary or mandibular single tooth extraction at the PUCRS university - Porto Alegre - Brazil.

    1. > 18 years of age
    2. non-molar tooth indicated for extraction
    3. intact sockets upon extractions
    4. Patients using removable provisional prosthesis (accessible to remove possible contact with surgical site) or patients without prosthesis after tooth extraction.

Exclusion Criteria:

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Negative control group
A negative control group will be applied without any type of alveolar preservation, only minimally invasive extraction.
Eksperimentel: Group test 1
Alveolar ridge preservation (ARP) using Bio-Oss Collagen® + Bio-Gide® exposed to the oral environment.
Procedure: Alveolar Ridge Reconstruction
Alveolar ridge preservation (ARP) using Bio-Oss Collagen® + Bio-Gide® exposed to the oral environment.
Procedure: Alveolar Ridge Reconstruction
ARP using Bio-Oss Collagen® + Mucograft® Seal® exposed to the oral environment.
Eksperimentel: Group test 2
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.
Procedure: Alveolar Ridge Reconstruction
ARP using Bio-Oss Collagen® + Mucograft® Seal® exposed to the oral environment.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Alveolar dimension changes (millimetres)
Tidsramme: From the surgery to the last follow-up at 3 months
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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Biomaterial contamination (colony count - bacterial colony number)
Tidsramme: Immediately after surgery to 21 days of follow-up
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.
Immediately after surgery to 21 days of follow-up
Radiographic alveolar bone dimensions (vertical and horizontal measures) in millimetres
Tidsramme: From the surgery to the last follow-up at 3 months
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.
From the surgery to the last follow-up at 3 months
Patient-related outcomes (OHIP-49 and VAS questionnaires) - score
Tidsramme: From the surgery to the last follow-up at 3 months.
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.
From the surgery to the last follow-up at 3 months.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Pontificia Universidade Católica do Rio Grande do Sul

Samarbejdspartnere

Geistlich Pharma AG

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. maj 2026

Primær færdiggørelse (Anslået)

1. maj 2027

Studieafslutning (Anslået)

1. oktober 2027

Datoer for studieregistrering

Først indsendt

5. maj 2026

Først indsendt, der opfyldte QC-kriterier

9. maj 2026

Først opslået (Faktiske)

15. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • CAAE 92555525.3.0000.5336
  • MTA 24-209 (Andet bevillings-/finansieringsnummer: Geistlich Pharma AG)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-deling Understøttende informationstype

  • SAP
  • ICF

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