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

October 7, 2024 updated by: Adrià Jorba García

Clinical and Histological Effects of the Adjunctive Use of Polynucleotide and Hyaluronic Acid-based Gel in Alveolar Preservation After Tooth Extraction: A Randomized Clinical Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Barcelona, Spain
        • Faculty of medicine and health sceince, University of Barcelona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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).
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).
Experimental: 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).
Procedure: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Histomorphometric results
Time Frame: 3 months
After 3 months of the ARP, A trephine with an internal diameter of 2.5 mm and a maximum length of 15 mm will be used to extract a bone core for histological analysis. Histological analyses will be performed on the entire sample area by calibrated and blinded examiners using open-source software (ImageJ, NIH). The areas of mineralized tissue and remaining xenograft material will be quantified based on their appearance and expressed as a percentage of the total area. The remaining area in the sample will be classified as non-mineralized tissue.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual evaluation of socket healing.
Time Frame: At 1 week and 12 weeks
Clinician will evaluate the healing of the socket based on a Healing index described by Avila-Ortiz, et al., 2018
At 1 week and 12 weeks
Implant insertion torque
Time Frame: 3 months
Implant insertion torque measured in N·cm
3 months
Need for additional bone regeneration for implant placement
Time Frame: 3 months
Evaluation of the feasibility to place dental implant without needing additional bone regeneration
3 months
Dimensional changes
Time Frame: Measurement at the day of the ARP and 3 months
Changes in the horizontal and vertical dimensions of the alveolar ridge after the ARP
Measurement at the day of the ARP and 3 months
Postoperative pain
Time Frame: During the first 7 postoperative days after ARP.
Visual Analog scale.
During the first 7 postoperative days after ARP.
Analgesic medication consumption
Time Frame: During the first 7 postoperative days after ARP.
Record of analgesics and anti-inflammatory drugs used
During the first 7 postoperative days after ARP.
Oral health related quality of life
Time Frame: At the day of the ARP and 7 days postoperative
Evaluation of the quality of life of the patient after an ARP procedure by means of the validated questionnaire OHIP-14
At the day of the ARP and 7 days postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Adrià Jorba García

Investigators

  • Principal Investigator: Adria Jorba Garcia, DDS, MS, University of Barcelona
  • Study Chair: Javier Bara-Casaus, MD, PhD, University of Barcelona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 15, 2024

Primary Completion (Estimated)

October 15, 2025

Study Completion (Estimated)

October 15, 2025

Study Registration Dates

First Submitted

October 7, 2024

First Submitted That Met QC Criteria

October 7, 2024

First Posted (Estimated)

October 9, 2024

Study Record Updates

Last Update Posted (Estimated)

October 9, 2024

Last Update Submitted That Met QC Criteria

October 7, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Regenfast

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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