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

NCT04781478 | Completed

• 1 other identifier: 2021-BIOCHD
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Periodontal Diseases

Keywords

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

Outcome Measures

Primary Outcomes (5)

• BOP% - Bleeding on Probing %

  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. Percentage of sites with bleeding on probing determines the BOP%.

  1, 3 and 6 months.

• PPD - 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.

  1, 3 and 6 months.

• R - Gingival recession

  Evaluation (in mm) of the distance between the gingival margin and the amelo-cemental junction (JEC). It is the exposure of the root surface, following the apical migration of periodontal structure.

  1, 3 and 6 months.

• PCR% - Plaque Control Record

  % assessment of the amount of plaque on dental surfaces; it is detected on 4 surfaces: distal, mesial, vestibular, lingual / palatal. The number of sites with plaque is divided by the total number of sites available in the mouth and multiplied by 100. Results indicate the index as a percentage.

  1, 3 and 6 months.

• Dental mobility (Miller, 1985)

  It is classified using numerical values: 0\. Grade 0: oscillation within 0.2 mm; the teeth move naturally and there are no mobility problems; 1. Grade I: horizontal mobility of the tooth from 0.2 to 1 mm; 2. Grade II: horizontal mobility of the tooth from 1 to 2 mm; 3. Grado III: horizontal mobility equal to or greater than 3 mm or vertical mobility of the tooth.

  1, 3 and 6 months.

Secondary Outcomes (1)

• Comparison between biorepair gel and chlorhexidine 1% gel

  1, 3 and 6 months.

Study Arms (2)

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

ACTIVE COMPARATOR

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

Other: Application of Biorepair Gel; Other: Irrigation of Chlorhexidine 1.00% gel

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

ACTIVE COMPARATOR

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

Other: Application of Biorepair Gel; Other: Irrigation of Chlorhexidine 1.00% gel

Interventions

Application of Biorepair Gel OTHER

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

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

Irrigation of Chlorhexidine 1.00% gel OTHER

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

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Presence of periodontal disease according to the recent 2017 classification (2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions):
• 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);
• Complexity from grade II onwards (grade II: maximum probing depth of 5 mm, bone loss mainly horizontally);
• Presence of bilateral periodontal probes, both to the right and to the left of the midline incisal line.
• Subjects who gave their written informed consent to take part of the study.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pavia: lead

Study Sites (1)

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

Pavia, Lombardy, 27100, Italy

Location

MeSH Terms

Conditions

Periodontal Diseases

Interventions

Gels

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Andrea Scribante, DDS, PhD.

  University of Pavia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Resident, Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: February 22, 2021
• First Posted: March 4, 2021
• Study Start: March 16, 2021
• Primary Completion: October 10, 2021
• Study Completion: October 15, 2021
• Last Updated: November 8, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)