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

ConditionPeri-implantitis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversitat Internacional de Catalunya

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

    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.

  • Non-Surgical Intervention

    Procedure/Surgery

    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

Treatment groups

32 Participants
are divided into 2 treatment groups
Group A: non-surgical therapyActive comparator 1 intervention
Group B: Test group: adjunctive PN-HA gelExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Probing pocket depth

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

Time frame
Baseline , 3 months, 6 months

Secondary outcomes

1

Modified plaque index

Modified Plaque Index (mPI) is a dental plaque scale as follows 0 = No plaque, 1 = Separate flecks of plaque at the cervical margin;2 = Plaque can be seen by naked eye.3 = Abundance of soft matter. The lower the number the less plaque is present on the tooth.

Time frame
Baseline , 3 months, 6 months
2

Modified bleeding index

This variable will be dichotomized in presence/absence of bleeding on probing (BoP) 0=No bleeding when a periodontal probe is passed along the mucosal margin adjacent to the implant, 1= Isolated bleeding spots visible, 2= Blood forms a confluent red line on mucosal margin, 3= Heavy or profuse bleeding

Time frame
Baseline , 3 months, 6 months
3

Bleeding on porbing

Bleeding on porbing will be assessed dichotomously in six sites per implant

Time frame
Baseline , 3 months, 6 months
4

Keratinized mucosa width

Keratinized mucosa width (mm) will be measured as the distance (mm) from the mucosal margin to the mucogingival junction at the mid-buccal aspect of the implant with the resin splint.

Time frame
Baseline , 3 months, 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universitat Internacional de Catalunya

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: