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Air Polishing as an Adjunct in Non-surgical Periodontal Therapy

NCT04178291 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2020-02-07

No results posted yet for this study

Summary

Periodontal disease is an infection that causes inflammation and destruction of the tooth supporting structures, and if untreated, will eventually lead to tooth loss. Periodontal disease has been identified as a significant contributor to the global burden of oral disease. This disease is reported to be the sixth most prevalent disease globally. Periodontal disease has an association with diabetes, cardiovascular diseases and preterm low birth weight babies. Therefore, treatment of this disease is necessary. Treatment of periodontal disease involves mechanical removal of oral biofilm. Biofilm removal is initially carried out via non-surgical periodontal therapy, with subgingival debridement being one of the most important steps. According to the first European Workshop on Periodontology, subgingival debridement comprises subgingival instrumentation to disrupt and remove the oral biofilm. Subgingival debridement involves various techniques including hand instrumentation and ultrasonic instrumentation. Recently, treatment modality such as air polishing is also gaining momentum. Air polishing was reported to be more comfortable than conventional periodontal therapy. Besides, a number of studies had portrayed similar clinical outcomes with the use of air polishing in comparison to conventional periodontal therapy. However, there is no study evaluating the health economic aspect of these treatment modalities. Health economic evaluation is a valuable evaluation in intervention studies. Such evaluations provide information on the best way of using available resources in health care settings. For instance, advances in health care technology have resulted in an array of alternative treatment options. Unfortunately, such options tend to cost more than the existing therapeutic approaches. Therefore, economic evaluations will identify the worth of the new treatment options in comparison to the gold standard, in this case, comparing the adjunctive use of air polishing with conventional periodontal therapy. Besides focusing at patient reported outcomes and cost effectiveness of air polishing, this prospective, parallel, single-blinded, randomised controlled clinical trial is also planned to investigate the clinical and biological responses after the adjunct use of Erythritol Powder Air Polishing (EPAP) in addition to root surface debridement (RSD).

Conditions

  • Periodontitis

Interventions

DEVICE

Ultrasonic scaler and Gracey currettes

Full mouth subgingival debridement using ultrasonic scaler and Gracey currettes

DEVICE

Air polishing with erythritol powder

Air flow PLUS

Sponsors & Collaborators

  • University of Malaya

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-01-31
Primary Completion
2021-01-31
Completion
2021-06-30

Countries

  • Malaysia

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04178291 on ClinicalTrials.gov