Chlorhexidine Gel and Peribioma Periogel Use in Peri-implant Mucositis Sites: a Split-mouth Randomized Clinical Trial.

NCT04899986 | Completed

• 1 other identifier: 2021-PBIMPLANT
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the efficacy of non-surgical periodontal therapy with supportive home oral care for the treatment of peri-implant mucositis. Patients with bilateral implants with peri-implant mucositis will undergo professional dental hygiene with ultrasonic handpiece and manual scaler, followed by the application of glycine Airflow powders. Then, patients will be randomly divided into two groups: the Trial Group will undergo a split-mouth application of chlorhexidine gel 1% for quadrants 1 and 4 and of Biorepair Periogel 0.12% for quadrants 2 and 3, with one daily home application for the following 15 days after the visits and the use of Biorepair Parodontogel toothpaste; the control Group will not use any gels. The improvement of peri-implant mucositis will be evaluated between the two groups and differences between the two gels will be assessed, if present.

Conditions

Peri-implant Mucositis

Keywords

non-surgical periodontal therapy

Outcome Measures

Primary Outcomes (8)

• Change in BOP - Bleeding On Probing

  Dichotomous scoring (yes/no)

  Baseline, 1, 3 and 6 months.

• Change in GBI - Gingival Bleeding Index (percentage)

  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.

  Baseline, 1, 3 and 6 months.

• Change in suppuration

  Dichotomous scoring (yes/no)

  Baseline, 1, 3 and 6 months.

• Change in marginal mucosa condition

  Scoring criteria: * 0: normal mucosa * 1: minimal inflammation with color change and minor edema * 2: moderate inflammation with redness, edema and glazing * 3: severe inflammation with redness, edema, ulceration and spontaneous bleeding without probing

  Baseline, 1, 3 and 6 months.

• Change in mucosal margin

  Dichotomous scoring (migrated/non migrated)

  Baseline, 1, 3 and 6 months.

• Probing Pocket Depth

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

  Baseline, 1, 3 and 6 months.

• Change in PI - Plaque Index (percentage)

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

  Baseline, 1, 3 and 6 months.

• Change in BS - Bleeding Score

  Scoring criteria: * 0: no bleeding * 1: isolated visible spots * 2: blood forms a confluent red line on mucosal margin * 3: heavy or profuse bleeding

  Baseline, 1, 3 and 6 months.

Study Arms (2)

Trial Group

EXPERIMENTAL

Patients from this group will use chlorhexidine Biorepair gel and toothpaste for home oral care.

Other: Chlorhexidine and Biorepair gel and toothpaste application

Control Group

ACTIVE COMPARATOR

Patients from this group will not use chlorhexidine and Biorepair gels and toothpastes, but will perform home oral care with standard toothpastes.

Other: Standard oral hygiene

Interventions

Chlorhexidine and Biorepair gel and toothpaste application OTHER

Split-mouth application of chlorhexidine gel 1% (quadrants 1 and 4) and Biorepair Periogel (quadrants 2 and 3) after professional dental hygiene. Home oral care will be continued with chlorhexidine 0,12% gel and Biorepair Periogel in the same quadrants, for the following 15 days from the visits, together with the use of Biorepair Parodontogel toothpaste.

Trial Group

Standard oral hygiene OTHER

Use of standard toothpastes for home oral hygiene.

Control Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (18-70 years)
• Bilateral presence of peri-implant mucositis
• Patients with high compliance

You may not qualify if:

• Patient with cardiac pacemaker
• Patients suffering from psychological, neurological or psychiatric disorders
• Patients suffering from systemic, metabolic or autoimmune diseases
• Pregnant women

Sponsors & Collaborators

• University of Pavia: lead

Study Sites (1)

Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia

Pavia, Lombardy, 27100, Italy

Location

MeSH Terms

Interventions

Chlorhexidine

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Andrea Scribante, DDS, PhD.

  University of Pavia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Resident, Principal Investigator

Study Record Dates

• First Submitted: May 19, 2021
• First Posted: May 25, 2021
• Study Start: May 15, 2021
• Primary Completion: January 14, 2022
• Study Completion: January 16, 2022
• Last Updated: January 31, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)