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

Peri-implant Mucositis Clinical Trial

Official title:

Clinical Comparison Between Chlorhexidine Gel and Peribioma Periogel in Patients With Peri-implant Mucositis: a Split-mouth Randomized Clinical Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04899986
• Other study ID #: 2021-PBIMPLANT
• Status: Completed
• Phase: N/A
• Start date: May 15, 2021
• Est. completion date: January 16, 2022

Study information

• Verified date: January 2022
• Source: University of Pavia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 16, 2022
• Est. primary completion date: January 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Mucositis
• Peri-implant Mucositis

Intervention

Other:
• Chlorhexidine and Biorepair gel and toothpaste application
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.
• Standard oral hygiene
Use of standard toothpastes for home oral hygiene.

Locations

Country	Name	City	State
Italy	Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia	Pavia	Lombardy

Sponsors (1)

Lead Sponsor	Collaborator
University of Pavia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in BOP - Bleeding On Probing	Dichotomous scoring (yes/no)	Baseline, 1, 3 and 6 months.
Primary	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.
Primary	Change in suppuration	Dichotomous scoring (yes/no)	Baseline, 1, 3 and 6 months.
Primary	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.
Primary	Change in mucosal margin	Dichotomous scoring (migrated/non migrated)	Baseline, 1, 3 and 6 months.
Primary	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.
Primary	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.
Primary	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.