Bone SubstitutesNCT06633211

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

A study testing Alveolar ridge preservation using DBBM + Regenfast + collagen matrix and Alveolar ridge preservation using DBBM + collagen matrix in people with Bone Substitutes and Tooth Extraction Status Nos, run by Adrià Jorba García at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Bone Substitutes, Tooth Extraction Status Nos
What is being tested?: Alveolar ridge preservation using DBBM + Regenfast + collagen matrix and Alveolar ridge preservation using DBBM + collagen matrix
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteSpain
Study dates: 15 Oct 2024to 15 Oct 2025
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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).

Trial locations and contacts

1 site in 1 country.

Adria Jorba garcia, DDS, MS contact

+34 699183949

adriajorba@hotmail.com

Spain1 site

Faculty of medicine and health sceince, University of Barcelona
Barcelona

Other trials in Spain

About this study

Official title: 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.

Conditions: Bone Substitutes, Tooth Extraction Status Nos
Being tested: Alveolar ridge preservation using DBBM + Regenfast + collagen matrix, Alveolar ridge preservation using DBBM + collagen matrix
Keywords: Alveolar Ridge preservation, Guided bone regeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Alveolar ridge preservation using DBBM + Regenfast + collagen matrixProcedure or surgery
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).
Alveolar ridge preservation using DBBM + collagen matrixProcedure or surgery
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).

Study groups in NCT06633211
Study group	Role	What they receive
DBBM + collagen matrix	Active comparator	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). Receives: Procedure: Alveolar ridge preservation using DBBM + collagen matrix
DBBM + Regenfast + collagen matrix	Experimental	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). Receives: Procedure: Alveolar ridge preservation using DBBM + Regenfast + collagen matrix

What is being measured

The primary outcome is the main question the study is designed to answer.

Histomorphometric results
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.
Measured: 3 months

Secondary outcomes (7)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Oct 202415 Oct 2025

First posted9 Oct 2024
Study start15 Oct 2024 (estimated)
Primary completion15 Oct 2025 (estimated)
Study completion15 Oct 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Bone SubstitutesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Two parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 20 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06633211
Sponsor's protocol ID: Regenfast
Status last verified: Oct 2024
First submitted: 7 Oct 2024
Last updated: 9 Oct 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Tonetti MS, Jung RE, Avila-Ortiz G, Blanco J, Cosyn J, Fickl S, Figuero E, Goldstein M, Graziani F, Madianos P, Molina A, Nart J, Salvi GE, Sanz-Martin I, Thoma D, Van Assche N, Vignoletti F. Management of the extraction socket and timing of implant placement: Consensus report and clinical recommendations of group 3 of the XV European Workshop in Periodontology. J Clin Periodontol. 2019 Jun;46 Suppl 21:183-194. doi: 10.1111/jcpe.13131.
PubMed 31215112
Avila-Ortiz G, Chambrone L, Vignoletti F. Effect of alveolar ridge preservation interventions following tooth extraction: A systematic review and meta-analysis. J Clin Periodontol. 2019 Jun;46 Suppl 21:195-223. doi: 10.1111/jcpe.13057.
PubMed 30623987
Pilloni A, Rojas MA, Trezza C, Carere M, De Filippis A, Marsala RL, Marini L. Clinical effects of the adjunctive use of polynucleotide and hyaluronic acid-based gel in the subgingival re-instrumentation of residual periodontal pockets: A randomized, split-mouth clinical trial. J Periodontol. 2023 Mar;94(3):354-363. doi: 10.1002/JPER.22-0225. Epub 2022 Nov 23.
PubMed 36189651
de Brito Bezerra B, Mendes Brazao MA, de Campos ML, Casati MZ, Sallum EA, Sallum AW. Association of hyaluronic acid with a collagen scaffold may improve bone healing in critical-size bone defects. Clin Oral Implants Res. 2012 Aug;23(8):938-42. doi: 10.1111/j.1600-0501.2011.02234.x. Epub 2011 Jun 21.
PubMed 21689163
Cairo F, Cavalcanti R, Barbato L, Nieri M, Castelluzzo W, di Martino M, Pilloni A. Polynucleotides and Hyaluronic Acid (PN-HA) Mixture With or Without Deproteinized Bovine Bone Mineral as a Novel Approach for the Treatment of Deep Infrabony Defects: A Retrospective Case Series. Int J Periodontics Restorative Dent. 2025 Mar 6;45(2):153-163. doi: 10.11607/prd.7065.
PubMed 38363180

Want to know more?

Adria Jorba garcia, DDS, MS

+34 699183949

adriajorba@hotmail.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT06633211
Acronym / sponsor ID: Regenfast
Conditions: Bone Substitutes, Tooth Extraction Status Nos
Keywords: Alveolar Ridge preservation, Guided bone regeneration
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 20 participants (estimated)
Lead sponsor: Adrià Jorba GarcíaUniversity, hospital or other
Study start: 15 Oct 2024 (estimated)
Primary completion: 15 Oct 2025 (estimated)
Study completion: 15 Oct 2025 (estimated)
First posted: 9 Oct 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2
Model description: Two parallel groups

Arm	Type	Receives
DBBM + collagen matrix	Active comparator	Procedure: Alveolar ridge preservation using DBBM + collagen matrixAn 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).
DBBM + Regenfast + collagen matrix	Experimental	Procedure: Alveolar ridge preservation using DBBM + Regenfast + collagen matrixAn 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).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (6 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Alveolar ridge preservation using DBBM + Regenfast + collagen matrixPost 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).	Procedure or surgery	DBBM + Regenfast + collagen matrix
Alveolar ridge preservation using DBBM + collagen matrixPost 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).	Procedure or surgery	DBBM + collagen matrix

Primary outcome

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.

7 secondary outcomes

Visual evaluation of socket healing.
Time frame: At 1 week and 12 weeks
Implant insertion torque
Time frame: 3 months
Need for additional bone regeneration for implant placement
Time frame: 3 months
Dimensional changes
Time frame: Measurement at the day of the ARP and 3 months
Postoperative pain
Time frame: During the first 7 postoperative days after ARP.
Analgesic medication consumption
Time frame: 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

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
Background: PubMed 31215112Tonetti MS, Jung RE, Avila-Ortiz G, Blanco J, Cosyn J, Fickl S, Figuero E, Goldstein M, Graziani F, Madianos P, Molina A, Nart J, Salvi GE, Sanz-Martin I, Thoma D, Van Assche N, Vignoletti F. Management of the extraction socket and timing of implant placement: Consensus report and clinical recommendations of group 3 of the XV European Workshop in Periodontology. J Clin Periodontol. 2019 Jun;46 Suppl 21:183-194. doi: 10.1111/jcpe.13131.
Background: PubMed 30623987Avila-Ortiz G, Chambrone L, Vignoletti F. Effect of alveolar ridge preservation interventions following tooth extraction: A systematic review and meta-analysis. J Clin Periodontol. 2019 Jun;46 Suppl 21:195-223. doi: 10.1111/jcpe.13057.
Background: PubMed 36189651Pilloni A, Rojas MA, Trezza C, Carere M, De Filippis A, Marsala RL, Marini L. Clinical effects of the adjunctive use of polynucleotide and hyaluronic acid-based gel in the subgingival re-instrumentation of residual periodontal pockets: A randomized, split-mouth clinical trial. J Periodontol. 2023 Mar;94(3):354-363. doi: 10.1002/JPER.22-0225. Epub 2022 Nov 23.
Background: PubMed 21689163de Brito Bezerra B, Mendes Brazao MA, de Campos ML, Casati MZ, Sallum EA, Sallum AW. Association of hyaluronic acid with a collagen scaffold may improve bone healing in critical-size bone defects. Clin Oral Implants Res. 2012 Aug;23(8):938-42. doi: 10.1111/j.1600-0501.2011.02234.x. Epub 2011 Jun 21.
Background: PubMed 38363180Cairo F, Cavalcanti R, Barbato L, Nieri M, Castelluzzo W, di Martino M, Pilloni A. Polynucleotides and Hyaluronic Acid (PN-HA) Mixture With or Without Deproteinized Bovine Bone Mineral as a Novel Approach for the Treatment of Deep Infrabony Defects: A Retrospective Case Series. Int J Periodontics Restorative Dent. 2025 Mar 6;45(2):153-163. doi: 10.11607/prd.7065.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Adria Jorba garcia, DDS, MS contact

+34 699183949

adriajorba@hotmail.com

Adria Jorba Garcia, DDS, MS principal investigator

University of Barcelona

Javier Bara-Casaus, MD, PhD study chair

University of Barcelona

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Adria Jorba garcia, DDS, MS (+34 699183949, adriajorba@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Histomorphometric results (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06633211, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2024.