Clinical Trials Logo

Clinical Trial Summary

Dental plaque, known as dental biofilm, is implicated as the primary etiological agent responsible for oral inflammatory diseases. Matured form of dental plaque plays a major role in the pathogenicity of gingivitis; if not managed in early stages it results in a cascade of events leading to the destruction of periodontal tissues.

Effective plaque control techniques have been suggested that maintain dental biofilm at levels compatible with oral health and is the cornerstone for all preventive strategies to control oral diseases particularly gingivitis. To clean teeth and ensure effective plaque control, different mechanical means have been in use since centuries. However because of an inadequacy in plaque removal, different antimicrobial and antiplaque agents have been introduced in oral-care products.

The use of dentifrices has been recommended over the years as the ultimate way of preventing the incidence of oral diseases. Dentifrices have the anti-plaque and the anti-gingivitis capabilities due to their composition. Toothpastes and to a lesser extent toothpowders are common oral-care products used to eliminate plaque and other deposits from tooth surfaces. Existent literature has focused more on toothpaste and mouth rinse and derelicts toothpowder despite its difference owing to the absence of humectants. With the intention to advance the knowledge on this issue as well as close the research gap, this study was conducted to evaluate the efficacy of toothpowder in alleviating gingivitis, controlling dental plaque, and inhibiting extrinsic stains.

A single-blind, parallel arm randomized controlled trial (RCT) evaluated the efficacy of toothpowder against toothpaste through oral hygiene parameters of plaque and stain deposits on teeth and gingival inflammation. Plaque Index, Lobene Stain Index and Gingival Index were used as measures of oral hygiene.

The current RCT revealed that toothpowder and toothpaste were equally effective in both treatment and control groups from clinical perspective however toothpowder showed a statistically significant effectiveness as compared to toothpaste. Toothpowder, composed of calcium carbonate and essential oils, has demonstrated to be statistically more effective than toothpaste in controlling extrinsic dental staining, dental plaque and gingival inflammation.

Clinical Trial Description

A single-blind randomized controlled trial was conducted during November 2010 and October 2011. After screening and consent, eligible subjects received mechanical periodontal therapy. Subjects were then randomized to Test group and Control group at a 1:1 ratio. The test group was provided tooth powder and a control group received toothpaste. Healthy subjects with plaque induced gingivitis and who fulfilled the inclusion criteria were recruited from the Department of Periodontology, Fatima Jinnah Dental College Hospital, Karachi, Pakistan.77 subjects with gingivitis were randomized to test group and 77 subjects to the control group. Therefore, to complete the randomized controlled trial, a total of 154 subjects were recruited and randomized.

Outcome measure gingivitis was measured through plaque index, gingival index and Lobene stain index. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT01902095
Study type Interventional
Source Sheikh Zayed Federal Postgraduate Medical Institute
Status Completed
Phase Phase 2
Start date November 2010
Completion date October 2011

See also
  Status Clinical Trial Phase
Completed NCT02884817 - Essential Oil+ELA, Plaque and Gingivitis Phase 4
Completed NCT02633345 - Effects on Tablets Containing Probiotic Candidate Strains N/A
Completed NCT02552589 - Effect of Toothpaste on the Reduction of Plaque and Inflammation N/A
Unknown status NCT01956656 - Efficacy Of Lotus Leaves In Management Of Plaque Induced Gingivitis 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
Completed NCT01941797 - Experimental Peri-implant Mucositis in Humans N/A
Completed NCT02508987 - Obesity and Oxidative Stress in Patients With Different Periodontal Status N/A
Unknown status NCT01197105 - Evaluation Study of a Mouthwash Based on Schinus Terebinthifolius to Treat Gingivitis in Children Phase 1/Phase 2
Completed NCT01593540 - Clinical Examination of Metal Free Interdental Brushes Phase 4
Completed NCT01236963 - Essential Oils Mouthrinse and Dental Floss, Comparison of Efficacy on Interproximal Gingivitis and Dental Plaque Accumulation N/A
Completed NCT02102295 - Effects of Antioxidant Dentifrice on Gingivitis Phase 3
Completed NCT02937636 - To Investigate the Gingivitis Efficacy of a Stannous Fluoride Dentifrice in a Chinese Population N/A
Recruiting NCT03641989 - Correlation Between Oral Health and Systemic Inflammation (COHESION) N/A
Recruiting NCT03765125 - Dietary Collagen Peptides and Periodontal Inflammation N/A
Completed NCT03030820 - Oral Gut Liver Axis in Cirrhosis N/A
Recruiting NCT02267239 - Methodology Antiseptic Application, Influence on Oral Biofilm. Phase 4
Completed NCT02138552 - Dose Finding Study to Assess Octenidine Mouthwash Concentrations in Comparison to Placebo Phase 2
Completed NCT01751178 - An Efficacy Study of Chlorhexidine Mouthwashes Phase 4