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Clinical Efficacy of Hybenix vs Chlosite Gels in Peri-implantitis

Sponsor
University of Pavia (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06083246
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
12.7
Anticipated Duration (Months)
3.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The present study is a randomized clinical trial (RCT). Patients responding to the inclusion criteria will be included. The following peri-implant indexes will be collected: Bleeding On Probing, Gingival Bleeding Index, Marginal Mucosal Conditions (swelling and erythema), Suppuration, Mucosal margin migration, PPD Probing Pocket Depth, Plaque Index, Bleeding Score, radiographic bone loss.

After the peri-implant evaluation, patients will undergo supragingival and subgingival professional oral hygiene of both arches performed with ultrasonic instrumentation with PEEK inserts, manual instrumentation with teflon curettes and air polishing with glycine powder.

After that, the sample will be randomly divided into 2 groups based on thein-office assigned treatment:

  • Chlosite® gel application in the peri-implant sulcus

  • Hybenix® gel application for 30 s followed by rinsing of the peri-implant sulcus.

The study will last 9 months. Patients will be visited at: T0, after 1 month from T0 (T1), after 3 months (T2), after 6 months (T3) and after 9 months (T4).

In each time frame, indexes collection and nonsurgical debridement will be performed.

Condition or Disease Intervention/Treatment Phase
  • Other: Hybenix gel
  • Other: Chlosite gel
 N/A

Detailed Description

The present study is designed as a randomized clinical trial (RCT) to evaluate the clinical efficacy of two adjuvant gels in the treatment of perimplantitis.

Patients responding to the inclusion criteria will be included in the study. The following peri-implant indexes will be collected:

  • BOP (Bleeding On Probing)

  • GBI (Gingival Bleeding Index)

  • Marginal Mucosal Conditions (swelling and erythema)

  • Suppuration

  • Mucosal margin migration

  • PPD (Probing Pocket Depth)

  • PI (Plaque Index)

  • BS (Bleeding Score)

  • Radiographic bone loss

After the peri-implant evaluation, patients will undergo supragingival and subgingival professional oral hygiene of both arches performed with ultrasonic instrumentation with PEEK inserts, manual instrumentation with teflon curettes and air polishing with glycine powder.

After that, the sample will be randomly divided into 2 groups based on thein-office assigned treatment:

  • Chlosite® gel application in the peri-implant sulcus

  • Hybenix® gel application for 30 s followed by rinsing of the peri-implant sulcus.

The study will last 9 months. Patients will be visited at: T0, after 1 month from T0 (T1), after 3 months (T2), after 6 months (T3) and after 9 months (T4).

In each time frame, indexes collection and nonsurgical debridement will be performed.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Efficacy of Hybenix and Chlosite Gels in Peri-implantitis Sites: a 9-month Randomized Clinical Trial.
Anticipated Study Start Date :
Oct 10, 2023
Anticipated Primary Completion Date :
Oct 20, 2024
Anticipated Study Completion Date :
Oct 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Hybenix gel

Clinical application of Hybenix gel.

Other: Hybenix gel
Clinical application of Hybenix gel after professional dental hygiene of peri-implant mucositis sites.
Active Comparator: Chlosite

Clinical application of Chlosite gel.

Other: Chlosite gel
Clinical application of Chlosite gel after professional dental hygiene of peri-implant mucositis sites.

Outcome Measures

Primary Outcome Measures

  1. Change in BOP - Bleeding On Probing [Baseline, 1, 3, 6 and 9 months.]

    Dichotomous scoring (yes/no)

  2. Change in GBI - Gingival Bleeding Index (percentage) [Baseline, 1, 3, 6 and 9 months.]

    Site-specific assessment of the presence or absence of gum bleeding after the insertion of the periodontal probe for the detection of PPD, detected on 6 sites. The number of bleeding sites is divided per the total number of probed sites; the ratio is multiplied X 100.

  3. Change in marginal mucosa condition [Baseline, 1, 3, 6 and 9 months.]

    Scoring criteria: 0: normal mucosa minimal inflammation with color change and minor edema moderate inflammation with redness, edema and glazing severe inflammation with redness, edema, ulceration and spontaneous bleeding without probing

  4. Change in suppuration [Baseline, 1, 3, 6 and 9 months.]

    Dichotomous scoring (yes/no)

  5. Marginal mucosal migration [Baseline, 1, 3, 6 and 9 months.]

    Dichotomous scoring (yes/no)

  6. Probing Depth [Baseline, 1, 3, 6 and 9 months.]

    Evaluation (in mm) of the depth of the mucosal sulcus, through a millimeter periodontal probe; it is detected from the mucosal margin to the bottom of the peri-implant sulcus, evaluated at 6 sites.

  7. Change in BS - Bleeding Score [Baseline, 1, 3, 6 and 9 months.]

    Scoring criteria: 0: no bleeding isolated visible spots blood forms a confluent red line on mucosal margin heavy or profuse bleeding

  8. Change in PI - Plaque Index (percentage) [Baseline, 1, 3, 6 and 9 months.]

    Evaluation of the presence of plaque on the 4 surfaces of teeth on the total amount of dental surfaces.

  9. Change in Radiographic bone loss (percentage) [Baseline, 1, 3, 6 and 9 months.]

    Quantitative evaluation of the bone loss evaluated on intraoral x-rays.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Presence of at least one peri-implant site with perimplantitis diagnosed according to the latest Classification of Periodontal and Peri-Implant Diseases and Conditions [Berglundh et al., 2018]: i) presence of bleeding and/or suppuration on gentle probing; ii) increased probing depth compared to previous examinations; iii) presence of bone loss beyond crestal bone level changes resulting from initial bone remodeling. In absence of previous examinations, the following criteria are considered: i) presence of bleeding and/or suppuration on gentle probing; ii) probing depths of ≥ 6 mm; iii) bone levels ≥ 3 mm apical of the most coronal portion of the intraosseous part of the implant, evaluated with intraoral x-rays with Rinn holders
Exclusion Criteria:

  • Patient with cardiac pacemaker

  • Patients suffering from psychological, neurological or psychiatric disorders

  • Patients suffering from systemic, metabolic or autoimmune diseases

  • Pregnant women

Contacts and Locations

Locations

Site City State Country Postal Code
1 Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia Pavia Lombardy Italy 27100

Sponsors and Collaborators

  • University of Pavia

Investigators

  • Principal Investigator: Andrea Scribante, DDS, PhD, MSc, University of Pavia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Andrea Scribante, Associate Professor, Principal Investigator, University of Pavia
ClinicalTrials.gov Identifier:
NCT06083246
Other Study ID Numbers:
  • 2023-IMPLGEL
First Posted:
Oct 13, 2023
Last Update Posted:
Oct 13, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Andrea Scribante, Associate Professor, Principal Investigator, University of Pavia
Chlorhexidine
Hybenix gel
Domiciliary treatments
Additional relevant MeSH terms:
Peri-Implantitis

Study Results

No Results Posted as of Oct 13, 2023