Clinical trial NCT04899986: Chlorhexidine Gel and Peribioma Periogel Use in Peri-implant Mucositis Sites: a Split-mouth Randomized Clinical Trial.
Official title: Clinical Comparison Between Chlorhexidine Gel and Peribioma Periogel in Patients With Peri-implant Mucositis: a Split-mouth Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peri-implant Mucositis
Keywords: non-surgical periodontal therapy
Lead sponsor: University of Pavia
Sponsor class: OTHER
First posted: 2021-05-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in BOP - Bleeding On Probing
timeFrame: Baseline, 1, 3 and 6 months.
measure: Change in GBI - Gingival Bleeding Index (percentage)
timeFrame: Baseline, 1, 3 and 6 months.
measure: Change in suppuration
timeFrame: Baseline, 1, 3 and 6 months.
measure: Change in marginal mucosa condition
timeFrame: Baseline, 1, 3 and 6 months.
measure: Change in mucosal margin
timeFrame: Baseline, 1, 3 and 6 months.
measure: Probing Pocket Depth
timeFrame: Baseline, 1, 3 and 6 months.
measure: Change in PI - Plaque Index (percentage)
timeFrame: Baseline, 1, 3 and 6 months.
measure: Change in BS - Bleeding Score
timeFrame: Baseline, 1, 3 and 6 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia
state: Lombardy
Study officials:
affiliation: University of Pavia
name: Andrea Scribante, DDS, PhD.
role: PRINCIPAL_INVESTIGATOR
References: