Polynucleotide and Hyaluronic Acid-based Gel as Adjunctive Therapy to Non- Surgical Treatment of Intraosseous Peri-implant Defect. A Randomized Clinical Trial

NCT06914518 | Not Yet Recruiting DMC

• 1 other identifier: PER-ECL-2023-06
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

Brief Summary

This randomized, placebo-controlled clinical trial evaluates the efficacy of a polynucleotide and hyaluronic acid-based gel (PN-HA) as adjunctive therapy to non-surgical flapless treatment of peri-implantitis. The main goal is to assess probing pocket depth (PPD) reduction after 6 months compared to placebo. Study Design:

• Type: Interventional (Clinical Trial)
• Allocation: Randomized (computer-generated blocks)
• Intervention Model: Parallel assignment
• Masking: Single-blind (examiner-blinded)
• Primary Purpose: Treatment
• Estimated Enrollment: 32 participants
• Duration: 6 month follow-up

Conditions

Peri-implantitis

Keywords

peri-implantitis; non-surgical treatment; non-surgical treatment per-implantitis; hyaluronic acid

Outcome Measures

Primary Outcomes (1)

• Probing pocket depth

  Peri-implant pocket depth: distance (mm) from the mucosal margin to the base of the probable pocket.

  Baseline , 3 months, 6 months

Secondary Outcomes (10)

• Modified plaque index

  Baseline , 3 months, 6 months

• Modified bleeding index

  Baseline , 3 months, 6 months

• Bleeding on porbing

  Baseline , 3 months, 6 months

• Keratinized mucosa width

  Baseline , 3 months, 6 months

• Bone level

  Baseline , 3 months, 6 months

Study Arms (2)

non-surgical therapy

ACTIVE COMPARATOR

Standardized peri-implant non-surgical therapy will be performed as follows: local anaesthesia (articaine 4% and adrenaline 1:100,000), debridement of the implant surfaces with ultrasonic devices (Newtron P5, Satelec Acteon; Olliergues, France) with the H3 dental ultrasonic scaler (H3, Satelec Acteon; Olliergues, France), curettage of the bone defect (SyG 7/89 Everdge, Hu-Friedy; Chicago, IL, USA) and supra- and submucosally cleaning using an air polisher with sub- gingival tip (EMS Air-flow® with erythritol-based powder containing)

Procedure: Non-Surgical Intervention

Test group: adjunctive PN-HA gel

EXPERIMENTAL

Standardized peri-implant non.surgical therapy will be performed as follows: local anaesthesia (articaine 4% and adrenaline 1:100,000), debridement of the implant surfaces with ultrasonic devices (Newtron P5, Satelec Acteon; Olliergues, France) with the H3 dental ultrasonic scaler (H3, Satelec Acteon; Olliergues, France), curettage of the bone defect (SyG 7/89 Everdge, Hu-Friedy; Chicago, IL, USA) and supra- and submucosally cleaning using an air polisher with sub- gingival tip (EMS Air-flow® with erythritol-based powder containing). At the end of the peri-implant non-surgical therapy a viscoelastic gel containing a fixed combination of natural origin PN (10 mg/ml, 1%) and HA with molecular weight \> 1500 kDa (10 mg/ml, 1%) (REGENFASTe, Mastelli S.r.l., Sanremo, Italy) will be injected in the peri-implant sulcus.

Other: viscoelastic gel containing a fixed combination of natural origin PN (10 mg/ml, 1%) and HA with molecular weight > 1500 kDa (10 mg/ml, 1%); Procedure: Non-Surgical Intervention

Interventions

viscoelastic gel containing a fixed combination of natural origin PN (10 mg/ml, 1%) and HA with molecular weight > 1500 kDa (10 mg/ml, 1%) OTHER

At the end of the standardized peri-implant non-surgical therapy a viscoelastic gel containing a fixed combination of natural origin PN (10 mg/ml, 1%) and HA with molecular weight \> 1500 kDa (10 mg/ml, 1%) (REGENFASTe, Mastelli S.r.l., Sanremo, Italy) will be injected in the peri-implant sulcus.

Test group: adjunctive PN-HA gel

Non-Surgical Intervention PROCEDURE

Standardized peri-implant non-surgical therapy will be performed as follows: local anaesthesia (articaine 4% and adrenaline 1:100,000), debridement of the implant surfaces with ultrasonic devices (Newtron P5, Satelec Acteon; Olliergues, France) with the H3 dental ultrasonic scaler (H3, Satelec Acteon; Olliergues, France), curettage of the bone defect (SyG 7/89 Everdge, Hu-Friedy; Chicago, IL, USA) and supra- and submucosally cleaning using an air polisher with sub- gingival tip (EMS Air-flow® with erythritol-based powder containing

Test group: adjunctive PN-HA gel; non-surgical therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with (I) ≥ 18 years of age, the presence of at least one implant diagnosed with peri-implantitis, intraosseous ≥ 3mm defects, presence of screw-retained single-unit crowns and partial dental prosthesis that allowed correct access for brushing; and, if not, prostheses that could be modified.

You may not qualify if:

• Subjects will be excluded from the study if they had received previous non-surgical peri-implantitis treatment during the last 6 months or surgical treatment, were pregnant or breast-feeding, had received antibiotic treatment in the previous 3 months, had systemic conditions that contraindicated treatment, smoking more than 10 cigarettes/day or presents a poor plaque control (Plaque Index \< 20%), implant mobility.

Sponsors & Collaborators

• Universitat Internacional de Catalunya: lead

Study Sites (2)

Clinica Universitaria ́̀ d'Odontologia - UIC Barcelona at the Periodontology Department

Sant Cugat del Vallès, Barcelona, 08195, Spain

Location

08195

Sant Cugat del Vallès, Bracelona, 08195, Spain

Location

Related Publications (7)

• Asparuhova MB, Kiryak D, Eliezer M, Mihov D, Sculean A. Activity of two hyaluronan preparations on primary human oral fibroblasts. J Periodontal Res. 2019 Feb;54(1):33-45. doi: 10.1111/jre.12602. Epub 2018 Sep 27.

  PMID: 30264516 BACKGROUND

• Rams TE, Degener JE, van Winkelhoff AJ. Antibiotic resistance in human chronic periodontitis microbiota. J Periodontol. 2014 Jan;85(1):160-9. doi: 10.1902/jop.2013.130142. Epub 2013 May 20.

  PMID: 23688097 BACKGROUND

• Pilloni A, Schmidlin PR, Sahrmann P, Sculean A, Rojas MA. Effectiveness of adjunctive hyaluronic acid application in coronally advanced flap in Miller class I single gingival recession sites: a randomized controlled clinical trial. Clin Oral Investig. 2019 Mar;23(3):1133-1141. doi: 10.1007/s00784-018-2537-4. Epub 2018 Jun 30.

  PMID: 29961138 BACKGROUND

• Blanco C, Pico A, Dopico J, Gandara P, Blanco J, Linares A. Adjunctive benefits of systemic metronidazole on non-surgical treatment of peri-implantitis. A randomized placebo-controlled clinical trial. J Clin Periodontol. 2022 Jan;49(1):15-27. doi: 10.1111/jcpe.13564. Epub 2021 Oct 28.

  PMID: 34713471 BACKGROUND

• Nart J, Pons R, Valles C, Esmatges A, Sanz-Martin I, Monje A. Non-surgical therapeutic outcomes of peri-implantitis: 12-month results. Clin Oral Investig. 2020 Feb;24(2):675-682. doi: 10.1007/s00784-019-02943-8. Epub 2019 May 23.

  PMID: 31123873 BACKGROUND

• Linares A, Sanz-Sanchez I, Dopico J, Molina A, Blanco J, Montero E. Efficacy of adjunctive measures in the non-surgical treatment of peri-implantitis: A systematic review. J Clin Periodontol. 2023 Jun;50 Suppl 26:224-243. doi: 10.1111/jcpe.13821. Epub 2023 May 4.

  PMID: 37143407 BACKGROUND

• Linares A, Pico A, Blanco C, Blanco J. Adjunctive Systemic Metronidazole to Nonsurgical Therapy of Peri-implantitis with Intrabony Defects: A Retrospective Case Series Study. Int J Oral Maxillofac Implants. 2019 Sep/Oct;34(5):1237-1245. doi: 10.11607/jomi.7343.

  PMID: 31528867 BACKGROUND

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Cristina Valles, Dentistry

  Department of Periodontology, Universitat Internacional de Catalunya

  PRINCIPAL INVESTIGATOR

Central Study Contacts

MARIA C SOLDINI, dentistry

CONTACT

+393491302895; MARIACOSTANZA.SOLDIN@UIC.ES

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2025
• First Posted: April 6, 2025
• Study Start: September 20, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)