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Completed

NCT Number: NCT04899986

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

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.

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Key information

Conditions

Peri-implant Mucositis

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 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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Chlorhexidine and Biorepair gel and toothpaste application

Other

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.

Standard oral hygiene

Other

Use of standard toothpastes for home oral hygiene.

Primary outcomes

  1. Change in BOP - Bleeding On Probing

    Time frame: Baseline, 1, 3 and 6 months.

    Dichotomous scoring (yes/no)

  2. Change in GBI - Gingival Bleeding Index (percentage)

    Time frame: Baseline, 1, 3 and 6 months.

    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.

  3. Change in suppuration

    Time frame: Baseline, 1, 3 and 6 months.

    Dichotomous scoring (yes/no)

  4. Change in marginal mucosa condition

    Time frame: Baseline, 1, 3 and 6 months.

    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

  5. Change in mucosal margin

    Time frame: Baseline, 1, 3 and 6 months.

    Dichotomous scoring (migrated/non migrated)

  6. Probing Pocket Depth

    Time frame: Baseline, 1, 3 and 6 months.

    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.

  7. Change in PI - Plaque Index (percentage)

    Time frame: Baseline, 1, 3 and 6 months.

    Evaluation of the presence of plaque on the 4 surfaces of teeth on the total amount of dental surfaces.

  8. Change in BS - Bleeding Score

    Time frame: Baseline, 1, 3 and 6 months.

    Scoring criteria:

    • 0: no bleeding
    • 1: isolated visible spots
    • 2: blood forms a confluent red line on mucosal margin
    • 3: heavy or profuse bleeding

Sponsors and collaborators

Lead sponsor

University of Pavia

Other

Registry information

Official study title

Clinical Comparison Between Chlorhexidine Gel and Peribioma Periogel in Patients With Peri-implant Mucositis: a Split-mouth Randomized Clinical Trial.

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 25, 2021
Registry last updated
Jan 31, 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.

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