Clinical trial NCT06633211: Adjunctive Use of Polynucleotide and Hyaluronic Acid-based Gel in Alveolar Preservation After Tooth Extraction
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Bone Substitutes
Tooth Extraction Status Nos
Keywords: Alveolar Ridge preservation
Guided bone regeneration
Lead sponsor: University of Barcelona
Sponsor class: OTHER
First posted: 2024-10-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two parallel groups
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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).

Primary outcomes:
measure: Histomorphometric results
timeFrame: 3 months
Secondary outcomes:
measure: Visual evaluation of socket healing.
timeFrame: At 1 week and 12 weeks
measure: Implant insertion torque
timeFrame: 3 months
measure: Need for additional bone regeneration for implant placement
timeFrame: 3 months
measure: Dimensional changes
timeFrame: Measurement at the day of the ARP and 3 months
measure: Postoperative pain
timeFrame: During the first 7 postoperative days after ARP.
measure: Analgesic medication consumption
timeFrame: During the first 7 postoperative days after ARP.
measure: Oral health related quality of life
timeFrame: At the day of the ARP and 7 days postoperative
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Faculty of medicine and health sceince, University of Barcelona
Study officials:
affiliation: University of Barcelona
name: Adria Jorba Garcia, DDS, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Barcelona
name: Javier Bara-Casaus, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.