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Treatment of Periodontal Disease With Two Different Bioactive Gels for Home Oral Care

NCT ID: NCT04781478

Last Updated: 2021-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-16

Study Completion Date

2021-10-15

Brief Summary

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This study is an open-label split-mouth study in which periodontal patients will be treated in order to obtain periodontal health. After non-surgical therapy and air-perio polishing, a periodontal in-situ gelling product (Biorepair Implant Bioactive gel) will be applied in periodontal pockets in two quadrants (Q1-Q3 or Q2-Q4) of the mouth of the participants. At the same time, pockets of the contralateral quadrant will be irrigated with chlorhexidine gel 1%. Patients will continue to use gels at home for the following 14 days and on the same quadrants. Professional ora hygiene session will be performed after 1, 3 and 6 months from the baseline.

Patients are divided into two groups with inverted quadrants administration in order to evaluate the improvements of periodontal inflammation indices and to assess the efficacy of Biorepair Implant Bioactive gel compared to chlorhexidine 1% gel treatment.

Detailed Description

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This study is an open-label split-mouth study that aims to assess the improvement of periodontal inflammatory indices after sessions of professional oral hygiene with the administration of Biorepair Implant Bioactive Gel and Chlorhexidine gel 1%. It will also compare the efficacy of the two gel in rebalancing periodontal health.

Periodontal patients that will give the informed consent to the treatment protocol and that satisfy the eligibility criteria will undergo 4 sessions of professional oral hygiene. For each session, periodontal inflammatory indices will be recorded and professional manual and mechanical removal of supragingival and subgingival deposits of both arches will be performed, following air-perio polishing with glycine powders. At this stage, patients will be randomized and allocated to the following two groups:

* Group 1: application in periodontal pockets of quadrants Q1 and Q3 of Biorepair Implant Bioactive Gel; irrigation of periodontal pockets of quadrants Q2 and Q4 with chlorhexidine 1% gel.
* Group 2: irrigation of periodontal pockets of quadrants Q1 and Q3 with chlorhexidine 1% gel; application in periodontal pockets of quadrants Q2 and Q4 of Biorepair Implant Bioactive Gel.

Patients will continue with a home oral care protocol, using both gels for the same quadrants of their group for the following 14 days after the professional oral hygiene session.

The first session is at the baseline (T0), the second is after 1 month (T1), the third is after 3 months (T2) and the last is after 6 months (T4).

Conditions

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Periodontal Diseases

Keywords

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split-mouth periodontal gel scaling and root planning periodontal disease dental hygiene

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients are divided in two groups. Both groups are treated with non-surgical periodontal therapy (baseline and 1, 3, 6 months after the first professional oral hygiene). Patients in the first group receive Biorepair gel in quadrants Q1 and Q4 and chlorhexidine 1% gel in quadrants Q2 and Q3; for patients in the second group the situation is inverted. In this way, it is possible to compare the general periodontal condition and the quadrants treated with the two different gels.
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Biorepair Gel (Q1-Q3) and Chlorhexidine 1% gel (Q2-Q4)

The patients receive Biorepair Gel application in quadrants Q1 and Q3, whereas they receive chlorhexidine 1% gel in quadrants Q2 and Q4.

Group Type ACTIVE_COMPARATOR

Application of Biorepair Gel

Intervention Type OTHER

Professional application of Biorepair Gel after Scaling and Root Planing and Air-Perio polishing (glycine powders).

Irrigation of Chlorhexidine 1.00% gel

Intervention Type OTHER

Irrigation of periodontal pockets with Chlorhexidine 1.00% gel afterScaling and Root Planing and Air-Perio polishing (glycine powders).

Chlorhexidine 1% gel (Q1-Q3) and Biorepair Gel (Q2-Q4)

The patients receive chlorhexidine 1% gel in quadrants Q1 and Q3, whereas they receive Biorepair Gel application in quadrants Q2 and Q4.

Group Type ACTIVE_COMPARATOR

Application of Biorepair Gel

Intervention Type OTHER

Professional application of Biorepair Gel after Scaling and Root Planing and Air-Perio polishing (glycine powders).

Irrigation of Chlorhexidine 1.00% gel

Intervention Type OTHER

Irrigation of periodontal pockets with Chlorhexidine 1.00% gel afterScaling and Root Planing and Air-Perio polishing (glycine powders).

Interventions

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Application of Biorepair Gel

Professional application of Biorepair Gel after Scaling and Root Planing and Air-Perio polishing (glycine powders).

Intervention Type OTHER

Irrigation of Chlorhexidine 1.00% gel

Irrigation of periodontal pockets with Chlorhexidine 1.00% gel afterScaling and Root Planing and Air-Perio polishing (glycine powders).

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Presence of periodontal disease according to the recent 2017 classification (2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions):

1.1 Severity from grade I onwards (grade I: clinical attachment loss of 1-2 mm, bone loss in the cervical third greater than 15%, no elements loss for periodontitis);

1.2. Complexity from grade II onwards (grade II: maximum probing depth of 5 mm, bone loss mainly horizontally);
2. Presence of bilateral periodontal probes, both to the right and to the left of the midline incisal line.
3. Subjects who gave their written informed consent to take part of the study.

Exclusion Criteria

* Patient with cardiac pacemaker
* Patients suffering from psychological, neurological or psychiatric disorders
* Pregnant or breastfeeding women
* Cancer patients undergoing therapy
* Patients taking bisphosphonates within the last 12 months
* Patients with low compliance or inconsistent motivation
* Drug or alcohol users
* Presence of periodontal probes exclusively on the right or left side compared to the midline incisal line
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pavia

OTHER

Sponsor Role lead

Responsible Party

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Andrea Scribante

Research Resident, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrea Scribante, DDS, PhD.

Role: PRINCIPAL_INVESTIGATOR

University of Pavia

Locations

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

Pavia, Lombardy, Italy

Site Status

Countries

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Italy

Other Identifiers

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2021-BIOCHD

Identifier Type: -

Identifier Source: org_study_id