Adjunctive Use of Polynucleotide and Hyaluronic Acid-based Gel in Alveolar Preservation After Tooth Extraction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-15

Study Completion Date

2025-10-15

Brief Summary

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Alveolar ridge resorption after tooth extraction is a physiological process that continues throughout the patient's life due to the loss of the periodontal ligament and lack of mechanical stimulation. Alveolar ridge preservation (ARP) techniques aim to minimize dimensional changes in the ridge after tooth extraction. These techniques involve grafting the socket to fill the bed and/or sealing it with a biomaterial. Currently, there is a polynucleotide and hyaluronic acid-based gel (Regenfast®) on the market that has proven useful in treating residual periodontal defects. Hyaluronic acid-based gels also appear to enhance the regenerative potential of critical bone defects in both in-vitro studies on rats and clinical studies. Therefore, this study aims to evaluate the clinical and histological effects of polynucleotide and hyaluronic acid-based gel in alveolar preservation procedures.

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Detailed Description

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Conditions

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Bone Substitutes Tooth Extraction Status Nos

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two parallel groups

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Due to the interventional nature of the study, the surgeon cannot be blinded. A randomization sequence will be generated, and each patient will be assigned a number. To ensure allocation concealment, the surgeon will be blinded to the group assignment of each patient until just before performing the alveolar preservation procedure. The investigator responsible for conducting the radiological measurements and the histomorphometric study will be blinded to the patient's group assignment.

Study Groups

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DBBM + collagen matrix

An alveolar ridge preservation will be performed using particulate xenograft DBBM (Bio-Oss, Geistlich Pharma AG, Wolhusen, Switzerland), and the alveolus will be sealed with a collagen matrix (Mucograft Seal, Geistlich Pharma AG, Wolhusen, Switzerland).

Group Type ACTIVE_COMPARATOR

Alveolar ridge preservation using DBBM + collagen matrix

Intervention Type PROCEDURE

Post extraction sites be filled up to the level of the highest point of the alveolar bone crest using particulate DBBM xenograft (Bio-Oss, Geistlich Pharma AG, Wolhusen, Switzerland). The alveolus will be sealed with a porcine collagen membrane (Mucograft Seal, Geistlich Pharma AG, Wolhusen, Switzerland) and secured with 4-6 simple interrupted sutures (Resolon 6-0, Resorba Medical GmbH, Nuremberg, Germany).

DBBM + Regenfast + collagen matrix

An alveolar preservation will be performed by means of a particulate DBBM xenograft (Bio-Oss, Geistlich Pharma AG, Wolhusen, Switzerland) mixed with polynucleotide and hyaluronic acid-based gel (Regenfast®). The alveolus will be sealed with a porcine collagen membrane (Mucograft Seal, Geistlich Pharma AG, Wolhusen, Switzerland).

Group Type EXPERIMENTAL

Alveolar ridge preservation using DBBM + Regenfast + collagen matrix

Intervention Type PROCEDURE

Post extraction sites be filled up to the level of the highest point of the alveolar bone crest using particulate DBBM xenograft (Bio-Oss, Geistlich Pharma AG, Wolhusen, Switzerland) mixed with polynucleotide and hyaluronic acid-based gel (Regenfast®). The alveolus will be sealed with a porcine collagen membrane (Mucograft Seal, Geistlich Pharma AG, Wolhusen, Switzerland) and secured with 4-6 simple interrupted sutures (Resolon 6-0, Resorba Medical GmbH, Nuremberg, Germany).

Interventions

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Alveolar ridge preservation using DBBM + Regenfast + collagen matrix

Post extraction sites be filled up to the level of the highest point of the alveolar bone crest using particulate DBBM xenograft (Bio-Oss, Geistlich Pharma AG, Wolhusen, Switzerland) mixed with polynucleotide and hyaluronic acid-based gel (Regenfast®). The alveolus will be sealed with a porcine collagen membrane (Mucograft Seal, Geistlich Pharma AG, Wolhusen, Switzerland) and secured with 4-6 simple interrupted sutures (Resolon 6-0, Resorba Medical GmbH, Nuremberg, Germany).

Intervention Type PROCEDURE

Alveolar ridge preservation using DBBM + collagen matrix

Post extraction sites be filled up to the level of the highest point of the alveolar bone crest using particulate DBBM xenograft (Bio-Oss, Geistlich Pharma AG, Wolhusen, Switzerland). The alveolus will be sealed with a porcine collagen membrane (Mucograft Seal, Geistlich Pharma AG, Wolhusen, Switzerland) and secured with 4-6 simple interrupted sutures (Resolon 6-0, Resorba Medical GmbH, Nuremberg, Germany).

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Adults (\>18 years) who need the extraction of a single non-molar tooth in the mandible or maxilla.
* ASA I or II
* Intact post-extraction socket or with only one wall dehiscence (buccal or lingual) of no more than 50% of the socket.
* The treatment plan must include the replacement of the tooth to be extracted by placing an implant and an implant-supported prosthesis.

Exclusion Criteria

* Mandibular incisors and molars.
* Acute infection associated with the tooth that needs to be extracted.
* Uncontrolled systemic disease.
* Pregnant patient.
* Patient under treatment with antiresorptives drugs (bisphosphonates or Receptor Activator of Nuclear Factor Kappa-B Ligand (i.e., Denosumab)) or antiangiogenics.
* Smokers (\>10 cigarettes a day).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes