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

U

University of Pavia

Status

Completed

Conditions

Peri-implant Mucositis

Treatments

Other: Standard oral hygiene
Other: Chlorhexidine and Biorepair gel and toothpaste application

Study type

Interventional

Funder types

Other

Identifiers

NCT04899986
2021-PBIMPLANT

Details and patient eligibility

About

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.

Full description

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:

  • Trial Group: split-mouth application of chlorhexidine gel 1% for quadrants 1 and 4 and of Biorepair Periogel 0.12% for quadrants 2 and 3. Home oral care will be continued with 1 application per day of the two gels for the following 15 days after the visits for the same quadrants, and the use of Biorepair Parodontogel Toothpaste.
  • Control Group: no application neither of chlorhexidine gel nor of Biorepair Periogel.

The improvement of peri-implant mucositis will be evaluated between the two groups and differences between the two gels will be assessed, if present, evaluating periodontal indices at the baseline, after three months and after six months.

Enrollment

20 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

20 participants in 2 patient groups

Trial Group
Experimental group
Description:
Patients from this group will use chlorhexidine Biorepair gel and toothpaste for home oral care.
Treatment:
Other: Chlorhexidine and Biorepair gel and toothpaste application
Control Group
Active Comparator group
Description:
Patients from this group will not use chlorhexidine and Biorepair gels and toothpastes, but will perform home oral care with standard toothpastes.
Treatment:
Other: Standard oral hygiene

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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