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Completed

NCT Number: NCT04733196

Clinical Effectiveness of 5 Different Mouthwashes in the Treatment of Generalised Gingivitis

The aim of the present study is to evaluate the efficacy of 5 mouthwashes, based on different ingredients, in the treatment of generalised gingivitis.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Blagovesta Yaneva

Plovdiv, 4000, Bulgaria

About this study

The present clinical study aims to investigate the clinical efficacy of 5 mouthwashes based on different active substances. The study include 180 patients divided into 6 groups of 30 patients, each group rinse with one of the following mouthwashes - mouthwash based on essential oils (menthol, thymol and eucalyptus), mouthwash based on essential oils (menthol, thymol and eucalyptus) and 0.12% chlorhexidine, mouthwash based on 0,8 % hydrogen peroxide, mouthwash based on prebiotic, water based on 0.2% chlorhexidine, placebo mouthwash. Inclusion criteria are: generalized gingival inflammation, plaque index of Turesky, 1970 > 1.95, gingival index of Loe & Silness, 1963 > 0.95, no systemic diseases, no systemic medication, lack of severely damaged teeth, no large fillings, no orthodontic treatment. Patients are motivated and instructed to maintain proper and optimal personal oral hygiene. All participants undergo professional mechanical plaque removal. After instrumentation participants are instructed to rinse with 15 ml mouthwash 2 times a day for 21 days. Researchers control the amount of mouthwash used by giving a new bottle of mouthwash with the required amount for 1 patient for 1 week at the beginning of each week and taking back the bottle from the previous week. During the study period, patients are monitored on days 14 and 21, examining plaque index of Turesky, 1970, gingival index of Loe & Silness, 1963, bleeding index of Ainamo & Bay, 1975, side effects like staining, burning itching, oral lesions. At the end of the study (day 21), patients complete a questionnaire.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Plaque Index (Turesky, 1970) > 1,95;
  • Gingival Index (Loe & Silness, 1963) > 0,95;
  • Bleeding Index (Animo & Bay, 1975) > 30 %;
  • no systemic diseases;
  • no systemic medication.

Exclusion criteria

  • severely destroyed teeth;
  • crowns;
  • non correct obturation class II and V;
  • orthodontic treatment;
  • third molars.

Treatment and study plan

Essential oils

Drug

Participants were asked to rinse with 15 ml mouthwash twice daily for 21 days.

Essential oils in combination with chlorhexidine 0,12%

Drug

Participants were asked to rinse with 15 ml mouthwash twice daily for 21 days.

Placebo Mouthwash

Drug

Participants were asked to rinse with 15 ml mouthwash twice daily for 21 days.

Chlorhexidine 0,20 % in combination with aroma oils

Drug

Participants were asked to rinse with 15 ml mouthwash twice daily for 21 days.

Prebiotic

Drug

Participants were asked to rinse with 15 ml mouthwash twice daily for 21 days.

Hydrogen peroxide 0,8 %

Drug

Participants were asked to rinse with 15 ml mouthwash twice daily for 21 days.

Primary outcomes

  1. Change from baseline bleeding index at 21 day.

    Time frame: 21 days

    Recording the bleeding index of Ainamo&Bay, 1975. The index reports the presence or absence of bleeding on probing in 4 sites around every tooth. It is calculated in % for the whole dentition.

Secondary outcomes

  1. Change from baseline gingival index at 21 day.

    Time frame: 21 days

    The gingival index of Loe, 1967 estimates the inflammation of the gingiva in 4 sites around every tooth, examining the colour, the texture, the consistency and the bleeding of the gingiva.

  2. Change from baseline oral hygiene index at 21 day.

    Time frame: 21 days

    The index of Turesky, 1970 is used. After discolouration of the plaque its distribution is measured in 6 sites of every tooth. The mean value is calculated by summing the individual values for each tooth and dividing the sum by all the places examined.

Sponsors and collaborators

Lead sponsor

Plovdiv Medical University

Other

Registry information

Official study title

Randomised Controlled Trial Comparing the Clinical Effectiveness of 5 Mouthwashes Based on Essential Oils, Chlorhexidine, Hydrogen Peroxide and Prebiotic, in Gingivitis Treatment

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Feb 1, 2021
Registry last updated
Feb 1, 2021

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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