In-office and Domiciliary Use of a New Ozonized Gel for the Management of Periodontal Disease

NCT05254288 | Completed

• 1 other identifier: 2022-OZORALPAROD
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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 periodontal disease. Patients with bilateral periodontal pathological sites will undergo professional dental hygiene with ultrasonic handpiece (Piezon EMS with PerioSlim inserts) followed by manual instrumentation with Gracey curettes and application of erythritol Airflow powders. Then, patients will be randomly divided into two groups according to a split-mouth design: the Control Group will undergo a split-mouth application of chlorhexidine gel 1% for quadrants 1/3 (or 2/4), while for the Trial Group Ozoral Pro for quadrants 2/4 (or 1/3) will be used. Patients will use the products at home with one daily application for the following 14 days after the visits. The Trial Group will use Ozoral Gel for home applications. The following indexes will be assessed at baseline, T1 (1 month), T2 (3 months) and T3 (6 months): recession, PPD, BoP %, CAL, PCR %. Contextually, the application of the two gels will be performed.

Conditions

Periodontal Diseases

Keywords

ozone; chlorhexidine; split-mouth

Outcome Measures

Primary Outcomes (5)

• Change in R - Gingival recession

  Distance (in mm) between the gingival margin and the amelo-cemental junction.

  Time Frame: baseline, 1, 3 and 6 months after baseline

• Change in 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.

  Time Frame: baseline, 1, 3 and 6 months after baseline

• Change in Bleeding on Probing (BOP%)

  Dichotomous scoring (yes/no) of bleeding sites

  Time Frame: baseline, 1, 3 and 6 months after baseline

• Change in Plaque Control Record (PCR%)

  % 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.

  Time Frame: baseline, 1, 3 and 6 months after baseline

• Change in Dental mobility (Miller, 1985)

  Scoring criteria * Grade 0: oscillation within 0.2 mm; the teeth move naturally and there are no mobility problems; * Grade I: horizontal mobility of the tooth from 0.2 to 1 mm; * Grade II: horizontal mobility of the tooth from 1 to 2 mm; * Grado III: horizontal mobility equal to or greater than 3 mm or vertical mobility of the tooth.

  Time Frame: baseline, 1, 3 and 6 months after baseline

Study Arms (2)

Split-mouth Group A

EXPERIMENTAL

Half of patients will be assigned to this group. Quadrants Q1/Q4 will receive ozone administration. Quadrants Q2/Q3 will receive chlorhexidine administration.

Other: Chlorhexidine; Other: Ozoral gels

Split-mouth Group B

EXPERIMENTAL

Half of patients will be assigned to this group Quadrants Q2/Q3 will receive ozone administration. Quadrants Q1/Q4 will receive chlorhexidine administration.

Other: Chlorhexidine; Other: Ozoral gels

Interventions

Chlorhexidine OTHER

In-office and domiciliary use of chlorhexidine for 14 days.

Split-mouth Group A; Split-mouth Group B

Ozoral gels OTHER

In-office administration of Ozoral Pro and domiciliary use of Ozoral gel for 14 days.

Split-mouth Group A; Split-mouth Group B

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 bilateral periodontal sites according to the new Classification of Periodontal and Peri-implant Diseases (Severity: Staging I; Complexity: Staging II).
• No systemic disease;
• Compliant patients.

You may not qualify if:

• Absence of dental implants;
• Neurological and psychiatric diseases;
• Patients taking bisphosphonates during the previous 12 months from the beginning of the study;
• Pregnant and/or breastfeeding women;
• Patients undergoing anticancer therapy.
• Patients with poor compliance.

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

Chlorhexidine

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Andrea Scribante, DDS, PhD, MS

  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
• Masking Details: Gels concealed
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Resident, Principal Investigator

Model Details: Split-mouth

Study Record Dates

• First Submitted: February 14, 2022
• First Posted: February 24, 2022
• Study Start: March 22, 2022
• Primary Completion: October 15, 2022
• Study Completion: October 19, 2022
• Last Updated: October 20, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)