Air Polishing as an Adjunct in Non-surgical Periodontal Therapy

NCT04178291 | Unknown

• 1 other identifier: 101269-4
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Periodontitis; air polishing; randomised clinical trial; adjunct; debridement

Outcome Measures

Primary Outcomes (1)

• Changes in probing pocket depth (PPD).

  Probing Pocket Depth (PPD) at 6 sites: Distance of margin of free gingiva to base of the pocket measured in millimetre using UNC-15 periodontal probe.

  6 months

Secondary Outcomes (6)

• Changes in clinical attachment level

  6 month

• Changes in recession

  6 month

• Changes in Periodontal inflamed surface area

  6 months

• Changes in full mouth bleeding score

  6 months

• Changes in full mouth plaque score

  6 months

Study Arms (2)

Conventional debridement and air polishing

EXPERIMENTAL

All participants will receive full mouth EPAP as an adjunct to RSD using ultrasonic scalers and Gracey currettes. The EPAP procedure will be performed using the Air-Flow Master R (EMS) equipment. For supragingival biofilm removal, the Air-Flow handpiece will be used, while the Perio-Flow handpiece with a disposable nozzle will be used for subgingival debridement at sites with PPD ≥ 5mm. No time limit is applicable for supragingival air polishing. However, for subgingival debridement, the nozzle will be inserted for 5 seconds into each pocket, and moved vertically up and down. Gracey currettes will be used at sites with PPD ≥ 5mm.

Device: Ultrasonic scaler and Gracey currettes; Device: Air polishing with erythritol powder

Conventional debridement

ACTIVE COMPARATOR

All participants will receive full mouth RSD using ultrasonic scalers and Gracey currettes. Gracey currettes will be used at sites with PPD ≥ 5mm.

Device: Ultrasonic scaler and Gracey currettes

Interventions

Ultrasonic scaler and Gracey currettes DEVICE

Full mouth subgingival debridement using ultrasonic scaler and Gracey currettes

Conventional debridement; Conventional debridement and air polishing

Air polishing with erythritol powder DEVICE

Air flow PLUS

Conventional debridement and air polishing

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 30-65 years old
• Healthy or well controlled systemic diseases, including diabetes (HbA1c\<7%) and hypertension (BP\<140/90 mm Hg)
• Diagnosed with moderate to severe periodontitis (Stage II and III) regardless of grade (Caton et al. 2017)
• \>20 remaining teeth

You may not qualify if:

• Systemic conditions requiring antibiotic prophylaxis
• Pregnant or breast feeding women
• Immunosuppressive therapy
• Immunocompromised such as HIV/AIDS patients
• Periodontal therapy in the last 6 months
• Antibiotic or anti-inflammatory therapy in the last 4 months
• Known hypersensitivity to sugar alcohol (polyol)
• Physical limitations or restrictions that prevent normal oral hygiene procedures
• Heavy smoker who smokes ≥ 1 pack of cigarettes per day
• Plaque score \> 30%
• Probing pocket depth \> 6mm

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

Nor Adinar Baharuddin

Kuala Lumpur, Selangor, 50603, Malaysia

RECRUITING

Related Publications (25)

• Savage A, Eaton KA, Moles DR, Needleman I. A systematic review of definitions of periodontitis and methods that have been used to identify this disease. J Clin Periodontol. 2009 Jun;36(6):458-67. doi: 10.1111/j.1600-051X.2009.01408.x.

  PMID: 19508246 BACKGROUND

• Moene R, Decaillet F, Andersen E, Mombelli A. Subgingival plaque removal using a new air-polishing device. J Periodontol. 2010 Jan;81(1):79-88. doi: 10.1902/jop.2009.090394.

  PMID: 20059420 BACKGROUND

• Laleman I, Cortellini S, De Winter S, Rodriguez Herrero E, Dekeyser C, Quirynen M, Teughels W. Subgingival debridement: end point, methods and how often? Periodontol 2000. 2017 Oct;75(1):189-204. doi: 10.1111/prd.12204.

  PMID: 28758304 BACKGROUND

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  PMID: 2366141 BACKGROUND

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  PMID: 12622860 BACKGROUND

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  PMID: 12702105 BACKGROUND

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  PMID: 9862657 BACKGROUND

• Hagi TT, Hofmanner P, Salvi GE, Ramseier CA, Sculean A. Clinical outcomes following subgingival application of a novel erythritol powder by means of air polishing in supportive periodontal therapy: a randomized, controlled clinical study. Quintessence Int. 2013 Nov-Dec;44(10):753-61. doi: 10.3290/j.qi.a30606.

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Related Links

• Glossary

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

Nor Shafina Mohamed Nazari, MScClinSDent

CONTACT

0379674806; shafina.mnazari@um.edu.my

Nor Adinar A Baharuddin, DClinDent

CONTACT

0196935088; noradinar@um.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 20, 2019
• First Posted: November 26, 2019
• Study Start: January 31, 2020
• Primary Completion: January 1, 2021
• Study Completion: June 1, 2021
• Last Updated: February 7, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)