Skip to main content
OpenTrials
Completed

NCT Number: NCT05254288

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Periodontal Diseases Mouth Diseases Stomatognathic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Pavia, Lombardy, 27100, Italy

About this study

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 comparing chlorhexidine and ozone gels.

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:

  • Control Group: application of chlorhexidine gel 1% for quadrants 1/3 (or 2/4)
  • Trial Group: administration of Ozoral Pro for quadrants 2/4 (or 1/3).

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Chlorhexidine

Other

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

Ozoral gels

Other

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

Primary outcomes

  1. Change in R - Gingival recession

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

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

  2. Change in PPD - Probing Pocket Depth

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

    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.

  3. Change in Bleeding on Probing (BOP%)

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

    Dichotomous scoring (yes/no) of bleeding sites

  4. Change in Plaque Control Record (PCR%)

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

    % 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.

  5. Change in Dental mobility (Miller, 1985)

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

    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.

Sponsors and collaborators

Lead sponsor

University of Pavia

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 24, 2022
Registry last updated
Oct 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.