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NCT Number: NCT05312593

Domiciliary Use of Hyaluronic Acid Gel Solutions vs Domiciliary Use of Chlorhexidine Mouthwash 0,20% for the Management of Peri-implant Mucositis Sites

This is a randomized controlled clinical trial (RCT). After signing the informed consent, patients satisfying the inclusion criteria will undergo supragingival and subgingival professional oral hygiene of both arches performed with ultrasonic instrumentation with PEEK inserts, manual instrumentation with PEEK curettes and air polishing with glycine powder.

After that, the sample will be randomly divided into 2 groups based on the domiciliary assigned treatment:

* Aftoral® Oral Gel solution with Hyaluronic Acid, Xylitol and glycerophosphoinositol for the domiciliary use for 15 days for 2 peri-implant mucositis sites. * Unidea® Chlorhexidine digluconate Mouthwash 0,20% administration for the domiciliary application for 15 days for 2 peri-implant sites.

The study will last 6 months. Patients will be visited at: T0, after 1 month from T0 (T1), after 3 months (T2), after 6 months (T3), after 9 months (T4) and after 12 months (T5). Professional hygiene will be performed again at T3.

At each recall session were collected a satisfaction questionnaire of the products (taste, smell, consistency, persistence and ease of application) and the following periodontal clinical indices, using a PEEK probe on each peri-implant site:

* conditions of the marginal mucosa (swelling and erythema), * migration of the marginal mucosa, * PPD (Probing Pocket Depth), * BOP% (Bleeding on Probing), * BS (Bleeding Score), * Suppuration, * PCR% (Plaque Control Record),

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Key information

Conditions

Peri-implant Mucositis

Age range

18 year–75 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

This is a randomized controlled clinical trial (RCT). 60 patients are expected to be enrolled. After signing the informed consent, patients satisfying the inclusion criteria will undergo supragingival and subgingival professional oral hygiene of both arches performed with ultrasonic instrumentation with PEEK inserts, manual instrumentation with PEEK curettes and air polishing with glycine powder.

After that, the sample will be randomly divided into 2 groups based on the domiciliary assigned treatment:

  • Aftoral® Oral Gel solution with Hyaluronic Acid, Xylitol and glycerophosphoinositol for the domiciliary use for 15 days for 2 peri-implant mucositis sites.
  • Unidea® Chlorhexidine digluconate Mouthwash 0,20% administration for the domiciliary application for 15 days for 2 peri-implant sites.

The study will last 6 months. Patients will be visited at: T0, after 1 month from T0 (T1), after 3 months (T2), after 6 months (T3), after 9 months (T4) and after 12 months (T5).

At T3, professional hygiene will be performed again.

At each recall session were collected a satisfaction questionnaire of the products (taste, smell, consistency, persistence and ease of application) and the following periodontal clinical indices, using a PEEK probe on each peri-implant site:

  • conditions of the marginal mucosa (swelling and erythema),
  • Marginal mucosal condition,
  • PPD (Probing Pocket Depth),
  • BOP% (Bleeding on Probing),
  • BS (Bleeding Score),
  • Suppuration,
  • PCR% (Plaque Control Record).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • age 18-70 years
  • presence of at least one site suffering from peri-implant mucositis with PPD > or equal to 5 mm
  • no systemic, metabolic and autoimmune disease
  • compliant patients

Exclusion criteria

  • absence of dental implants
  • neurologic, psychiatric and mental diseases
  • patients taking bisphosphonates in the last 12 months
  • patients taking antibiotics during the study
  • pregnant and breastfeeding women
  • patients undergoing anticancer treatment
  • allergy to chlorhexidine or hyaluronic acid
  • sites with peri-implantitis

Treatment and study plan

Aftoral Oral Gel

Other

Patients will use Aftoral® Oral Gel solution for the domiciliary application once a day for 15 days after the visits (no rinsing and eating for 30 minutes after gel solution application).

Unidea Chlorhexidine mouthwash

Other

Patients will use chlorhexidine mouthwash 0,20% for the domiciliary application once a day for 15 days after the visits (no rinsing and eating for 30 minutes after mouthwash application).

Primary outcomes

  1. Change in Probing Depth (PD)

    Time frame: Baseline (T0), after 1 (T1), 3 (T2), 6 (T3), 9 (T4) and 12 months (T5)

    Evaluation (in mm) of the depth of the gingival sulcus, through a millimeter periodontal PEEK probe; it is detected from the gingival margin to the bottom of the gingival sulcus or periodontal pocket, evaluated at 6 sites.

  2. Change in Bleeding on Probing (BOP%)

    Time frame: Baseline (T0), after 1 (T1), 3 (T2), 6 (T3), 9 (T4) and 12 months (T5)

    Quantitative assessment (percentage) of the bleeding sites (6 per tooth in total).

    Formula = n ° bleeding sites / n ° probed sites x100

  3. Change in Bleeding Score (BS - Mombelli et al.)

    Time frame: Baseline (T0), after 1 (T1), 3 (T2), 6 (T3), 9 (T4) and 12 months (T5)

    Scoring criteria:

    0: no bleeding

    • isolated visible spots
    • blood forms a confluent red line on the mucosal margin
    • profuse and copious bleeding

  4. Change in Plaque Control Record (PCR%)

    Time frame: Baseline (T0), after 1 (T1), 3 (T2), 6 (T3), 9 (T4) and 12 months (T5)

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

    Formula = n ° sites with plaque / total n ° of dental surfaces x100

  5. Change in marginal mucosa condition

    Time frame: Baseline (T0), after 1 (T1), 3 (T2), 6 (T3), 9 (T4) and 12 months (T5)

    Scoring criteria:

    0: normal mucosa

    • minimal inflammation with color change and minor edema
    • moderate inflammation with redness, edema and glazing
    • severe inflammation with redness, edema, ulceration and spontaneous bleeding without probing

  6. Change in Suppuration (%)

    Time frame: Baseline (T0), after 1 (T1), 3 (T2), 6 (T3), 9 (T4) and 12 months (T5)

    Dichotomous scoring (yes/no) of suppurating sites

Sponsors and collaborators

Lead sponsor

University of Pavia

Other

Registry information

Official study title

Domiciliary Use of Hyaluronic Acid Gel Solutions vs Domiciliary Use of Chlorhexidine Mouthwash 0,20% for the Management of Peri-implant Mucositis Sites: a Randomized Clinical Trial

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 5, 2022
Registry last updated
Jun 25, 2024

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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