Clinical Trials Logo

Clinical Trial Summary

Professional oral hygiene has become a customary procedure in everyday dentistry. Both manual and sonic brushes are part of normal oral hygiene education practice. Compared with manual toothbrushes, ergonomic instruments, such as sonic toothbrushes, can be a more practical and less demanding mean to remove biofilm and plaque efficiently. Studies in literature investigate the efficacy of toothbrushes in plaque removal, but the investiagator's study would validate efficacy of toothbrushes post-causal therapy, towards lower plaque accumulation, and reduction in bleeding.

The objective of this study is to compare two methods (manual VS sonic) of tooth brushing in terms of impact on the gingival index and plaque index after one session of Full Mouth-Erythritol Powder Air Polishing Therapy (FM-EPAPT) in healthy patients.

The hypothesis of the present randomized controlled trial is that sonic tooth brushing accumulates less plaque (-10%) than manual tooth brushing.

To test this hypothesis, the patients, upon initial evaluation, will be divided in 2 study groups and, after a session of professional oral hygiene, will be instructed to use:

- CONTROL: manual toothbrush

- TEST: sonic toothbrush. Gingival index and plaque score will be evaluated at 2, 4, 6 weeks and 6 and 12 months.


Clinical Trial Description

Everyone's goal to have a healthy mouth is the removal of biofilm, plaque and calculus from the dental surface everyday. Moreover routine recalls ensure a better oral health and greater protection against caries, gingivitis and periodontitis. Regular attendance to oral hygiene sessions plays an important role but has to be accompanied by the compliance with home oral care instructions. The patients should be adequately instructed to take care of their oral health.

TRIAL DESIGN: Monocetric, pragmatic, single blinded, randomized clinical trial (RCT) of parallel design.The trial will have one-year duration.

STUDY POPULATION: Healthy subject affected by gingivitis are included in the study. Presence of gingivitis is defined as bleeding on probing (BOP) > 25%.

PRIMARY OUTCOME: Change in Plaque Index (PI): change in 10% less of the site in test group.

SECONDARY OUTCOME:

- Change in Gingival Index (GI): change in presence or absence of bleeding after gently run on the surface of the marginal gingiva.

- Change in Recession (REC): change in gingival reduction.

- Change in Clinical Attachment Level (CAL): change in clinical attachment level. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04558606
Study type Interventional
Source Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Contact
Status Completed
Phase N/A
Start date January 8, 2018
Completion date January 23, 2019

See also
  Status Clinical Trial Phase
Not yet recruiting NCT05568290 - Interleukin-38 Levels in Individuals With Periodontitis
Completed NCT04402996 - Meteorin-like Levels in Individuals With Periodontitis
Not yet recruiting NCT06016023 - Evaluation of Macrophage Inflammatory Protein-1α as a Periodontal Disease Biomarker
Not yet recruiting NCT05497895 - The Assessment of Clinical Efficacy of Topical Application of 5% Thymoquinone Gel for Gingivitis Patients Early Phase 1
Completed NCT02884817 - Essential Oil+ELA, Plaque and Gingivitis Phase 4
Completed NCT02552589 - Effect of Toothpaste on the Reduction of Plaque and Inflammation N/A
Completed NCT02633345 - Effects on Tablets Containing Probiotic Candidate Strains N/A
Completed NCT02515929 - Prospective Double-Blind Randomized Controlled Clinical Trial in the Gingivitis Prevention With OPCs Phase 4
Completed NCT02235532 - Effects of Aloe Vera Toothpaste on Periodontal Parameters N/A
Completed NCT02980497 - Antiplaque/Antigingivitis Efficacy of Essential Oil Mouthrinses in Six-Month Study N/A
Unknown status NCT01956656 - Efficacy Of Lotus Leaves In Management Of Plaque Induced Gingivitis N/A
Completed NCT02508987 - Obesity and Oxidative Stress in Patients With Different Periodontal Status N/A
Completed NCT01941797 - Experimental Peri-implant Mucositis in Humans N/A
Completed NCT01593540 - Clinical Examination of Metal Free Interdental Brushes Phase 4
Unknown status NCT01197105 - Evaluation Study of a Mouthwash Based on Schinus Terebinthifolius to Treat Gingivitis in Children Phase 1/Phase 2
Completed NCT01236963 - Essential Oils Mouth Rinse and Dental Floss: Efficacy on Interproximal Gingivitis and Dental Plaque Accumulation N/A
Completed NCT02102295 - Effects of Antioxidant Dentifrice on Gingivitis Phase 3
Completed NCT06140784 - A Clinical Study to Assess the Gingivitis and Plaque Effects of Various Dentifrices N/A
Completed NCT02937636 - To Investigate the Gingivitis Efficacy of a Stannous Fluoride Dentifrice in a Chinese Population N/A
Completed NCT06212908 - Assessment of Periodontal Therapy and Biofilm Management in Breast Cancer N/A