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

Primary Purpose

Peri-implant Mucositis

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Chlorhexidine and Biorepair gel and toothpaste application
Standard oral hygiene
Sponsored by
University of Pavia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peri-implant Mucositis focused on measuring non-surgical periodontal therapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Trial Group

Control Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in BOP - Bleeding On Probing
Dichotomous scoring (yes/no)
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.
Change in suppuration
Dichotomous scoring (yes/no)
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
Change in mucosal margin
Dichotomous scoring (migrated/non migrated)
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.
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.
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

Secondary Outcome Measures

Full Information

First Posted
May 19, 2021
Last Updated
January 16, 2022
Sponsor
University of Pavia
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1. Study Identification

Unique Protocol Identification Number
NCT04899986
Brief Title
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

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
May 15, 2021 (Actual)
Primary Completion Date
January 14, 2022 (Actual)
Study Completion Date
January 16, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pavia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peri-implant Mucositis
Keywords
non-surgical periodontal therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Trial Group
Arm Type
Experimental
Arm Description
Patients from this group will use chlorhexidine Biorepair gel and toothpaste for home oral care.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Patients from this group will not use chlorhexidine and Biorepair gels and toothpastes, but will perform home oral care with standard toothpastes.
Intervention Type
Other
Intervention Name(s)
Chlorhexidine and Biorepair gel and toothpaste application
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard oral hygiene
Intervention Description
Use of standard toothpastes for home oral hygiene.
Primary Outcome Measure Information:
Title
Change in BOP - Bleeding On Probing
Description
Dichotomous scoring (yes/no)
Time Frame
Baseline, 1, 3 and 6 months.
Title
Change in GBI - Gingival Bleeding Index (percentage)
Description
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.
Time Frame
Baseline, 1, 3 and 6 months.
Title
Change in suppuration
Description
Dichotomous scoring (yes/no)
Time Frame
Baseline, 1, 3 and 6 months.
Title
Change in marginal mucosa condition
Description
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
Time Frame
Baseline, 1, 3 and 6 months.
Title
Change in mucosal margin
Description
Dichotomous scoring (migrated/non migrated)
Time Frame
Baseline, 1, 3 and 6 months.
Title
Probing Pocket Depth
Description
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.
Time Frame
Baseline, 1, 3 and 6 months.
Title
Change in PI - Plaque Index (percentage)
Description
Evaluation of the presence of plaque on the 4 surfaces of teeth on the total amount of dental surfaces.
Time Frame
Baseline, 1, 3 and 6 months.
Title
Change in BS - Bleeding Score
Description
Scoring criteria: 0: no bleeding 1: isolated visible spots 2: blood forms a confluent red line on mucosal margin 3: heavy or profuse bleeding
Time Frame
Baseline, 1, 3 and 6 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Scribante, DDS, PhD.
Organizational Affiliation
University of Pavia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia
City
Pavia
State/Province
Lombardy
ZIP/Postal Code
27100
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data will be available upon motivated request to Principal Investigator

Learn more about this trial

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

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