Compare Air Polishing With Ultrasonic During Maintenance

NCT04169945 | Unknown

• 1 other identifier: 101269-3
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Periodontal disease is a chronic multifactorial inflammatory disease that affects the soft and hard supporting tissues of the teeth. It is one of the most common oral health problems which 90% of the global adult population has been reported to have some form of the disease. Microorganisms in dental biofilm play a critical etiological factor in the development of this progressive destruction disease, and if left untreated, will eventually lead to tooth loss. Recurrent periodontal disease did occur in treated and well-maintained patients at different time intervals and is a site-specific disorder. Therefore, subgingival biofilm removal during supportive periodontal therapy has become a fundamental part in achieving a stable oral health after completion of active treatment. Subgingival debridement involves various techniques. In recent years, many studies have reported on the effectiveness of air polishing device using different powders versus conventional hand instruments and/or oscillating scalers. However, there is no study evaluating the health economic aspect of these treatment modalities. As development leads to advancement of treatment options, they often involve higher cost than the existing measures. Therefore, besides clinical efficacy, economic evaluation enables health decision makers to allocate limited health resources in a more efficient manner, to ensure best possible outcomes, without neglecting any segment of care.

Conditions

Periodontitis

Keywords

periodontitis; air polishing; randomised clinical trial; debridement

Outcome Measures

Primary Outcomes (1)

• Presence of pocket depth >4mm

  To determine presence of pocket depth \> 4 mm after 6 months

  6 months

Secondary Outcomes (4)

• Clinical attachment level gain (CAL)

  6 months

• Patient reported outcome measures (PROM)

  6 months

• Incremental Cost Effectiveness Ratio (ICER)

  6 months

• Patient reported outcome measures (PROM)

  6 months

Study Arms (2)

Ultrasonic instrumentation and Air Polishing

EXPERIMENTAL

All participants will receive full mouth conventional ultrasonic subgingival debridement, followed by air-polishing with erythritol powder which include activating device for 5 seconds of each surface (Petersilka 2003). Subsequently, Perio-Flow handpiece with a special disposable nozzle will be used for pocket depth \>4mm. Perio-Flow handpiece with a special disposable nozzle will be used for pocket depth \>4mm

Other: Ultrasonic instrumentation; Other: Air polishing with erythritol powder

Ultrasonic instrumentation

ACTIVE COMPARATOR

All participants will receive full mouth conventional ultrasonic subgingival debridement only. No time limit (Flemmig 2012), until dental surfaces feel smooth.

Other: Ultrasonic instrumentation

Interventions

Ultrasonic instrumentation OTHER

Full mouth root surface debridement

Ultrasonic instrumentation; Ultrasonic instrumentation and Air Polishing

Air polishing with erythritol powder OTHER

Air flow PLUS

Ultrasonic instrumentation 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:

• Patients aged 30 to 65 years old.
• Patients with at least 20 teeth available.
• Patients already in SPT at least 3 months after completion of comprehensive periodontal therapy.
• Presence of at least 4 teeth with residual pockets of ≥5mm and positive bleeding on probing.
• Patients with controlled systemic diseases.

You may not qualify if:

• Patients with a plaque control record \>30%.
• Patients who had undergone radiation or immunosuppressive therapy.
• Patients with cardiac pacemaker, defibrillators and any implantable electronic device.
• Patients who are on antibiotics, anti-inflammatory drugs or other medication taken within the previous 3 months.
• Patients who are confirmed or suspected intolerance to the test products.
• Patients with history or known case of root hypersensitivity.
• Patients with physical limitation that might hinder proper home care or oral hygiene procedures.
• Patients who are pregnant.

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

Faculty of Dentistry

Kuala Lumpur, 50603, Malaysia

RECRUITING

Related Publications (17)

• Drago L, Del Fabbro M, Bortolin M, Vassena C, De Vecchi E, Taschieri S. Biofilm removal and antimicrobial activity of two different air-polishing powders: an in vitro study. J Periodontol. 2014 Nov;85(11):e363-9. doi: 10.1902/jop.2014.140134. Epub 2014 Jul 25.

  PMID: 25060742 BACKGROUND

• Flemmig TF, Petersilka GJ, Mehl A, Hickel R, Klaiber B. The effect of working parameters on root substance removal using a piezoelectric ultrasonic scaler in vitro. J Clin Periodontol. 1998 Feb;25(2):158-63. doi: 10.1111/j.1600-051x.1998.tb02422.x.

  PMID: 9495615 BACKGROUND

• Hashino E, Kuboniwa M, Alghamdi SA, Yamaguchi M, Yamamoto R, Cho H, Amano A. Erythritol alters microstructure and metabolomic profiles of biofilm composed of Streptococcus gordonii and Porphyromonas gingivalis. Mol Oral Microbiol. 2013 Dec;28(6):435-51. doi: 10.1111/omi.12037. Epub 2013 Jul 29.

  PMID: 23890177 BACKGROUND

• Mohd-Dom TN, Wan-Puteh SE, Muhd-Nur A, Ayob R, Abdul-Manaf MR, Abdul-Muttalib K, Aljunid SM. Cost-Effectiveness of Periodontitis Management in Public Sector Specialist Periodontal Clinics: A Societal Perspective Research in Malaysia. Value Health Reg Issues. 2014 May;3:117-123. doi: 10.1016/j.vhri.2014.04.012. Epub 2014 May 20.

  PMID: 29702916 BACKGROUND

• Petersilka GJ, Bell M, Mehl A, Hickel R, Flemmig TF. Root defects following air polishing. J Clin Periodontol. 2003 Feb;30(2):165-70. doi: 10.1034/j.1600-051x.2003.300204.x.

  PMID: 12622860 BACKGROUND

• Sahrmann P, Ronay V, Schmidlin PR, Attin T, Paque F. Three-dimensional defect evaluation of air polishing on extracted human roots. J Periodontol. 2014 Aug;85(8):1107-14. doi: 10.1902/jop.2014.130629. Epub 2014 Jan 30.

  PMID: 24476548 BACKGROUND

• Wennstrom JL, Dahlen G, Ramberg P. Subgingival debridement of periodontal pockets by air polishing in comparison with ultrasonic instrumentation during maintenance therapy. J Clin Periodontol. 2011 Sep;38(9):820-7. doi: 10.1111/j.1600-051X.2011.01751.x. Epub 2011 Jul 7.

  PMID: 21736599 BACKGROUND

• Zappa U, Smith B, Simona C, Graf H, Case D, Kim W. Root substance removal by scaling and root planing. J Periodontol. 1991 Dec;62(12):750-4. doi: 10.1902/jop.1991.62.12.750.

  PMID: 1765938 BACKGROUND

• Buhler J, Schmidli F, Weiger R, Walter C. Analysis of the effects of air polishing powders containing sodium bicarbonate and glycine on human teeth. Clin Oral Investig. 2015 May;19(4):877-85. doi: 10.1007/s00784-014-1317-z. Epub 2014 Sep 21.

  PMID: 25240922 RESULT

• Farooqi OA, Wehler CJ, Gibson G, Jurasic MM, Jones JA. Appropriate Recall Interval for Periodontal Maintenance: A Systematic Review. J Evid Based Dent Pract. 2015 Dec;15(4):171-81. doi: 10.1016/j.jebdp.2015.10.001. Epub 2015 Nov 19.

  PMID: 26698003 RESULT

• Flemmig TF, Hetzel M, Topoll H, Gerss J, Haeberlein I, Petersilka G. Subgingival debridement efficacy of glycine powder air polishing. J Periodontol. 2007 Jun;78(6):1002-10. doi: 10.1902/jop.2007.060420.

  PMID: 17539712 RESULT

• Lindhe J, Nyman S. Long-term maintenance of patients treated for advanced periodontal disease. J Clin Periodontol. 1984 Sep;11(8):504-14. doi: 10.1111/j.1600-051x.1984.tb00902.x.

  PMID: 6384275 RESULT

• Lindhe J, Westfelt E, Nyman S, Socransky SS, Haffajee AD. Long-term effect of surgical/non-surgical treatment of periodontal disease. J Clin Periodontol. 1984 Aug;11(7):448-58. doi: 10.1111/j.1600-051x.1984.tb01344.x.

  PMID: 6378986 RESULT

• 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 RESULT

• Muller N, Moene R, Cancela JA, Mombelli A. Subgingival air-polishing with erythritol during periodontal maintenance: randomized clinical trial of twelve months. J Clin Periodontol. 2014 Sep;41(9):883-9. doi: 10.1111/jcpe.12289. Epub 2014 Aug 7.

  PMID: 25041441 RESULT

• Petersilka GJ, Steinmann D, Haberlein I, Heinecke A, Flemmig TF. Subgingival plaque removal in buccal and lingual sites using a novel low abrasive air-polishing powder. J Clin Periodontol. 2003 Apr;30(4):328-33. doi: 10.1034/j.1600-051x.2003.00290.x.

  PMID: 12694431 RESULT

• Petersilka GJ. Subgingival air-polishing in the treatment of periodontal biofilm infections. Periodontol 2000. 2011 Feb;55(1):124-42. doi: 10.1111/j.1600-0757.2010.00342.x. No abstract available.

  PMID: 21134232 RESULT

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

Nor Adinar Baharuddin, DClinDent

CONTACT

0196935088; noradinar@um.edu.my

Shafina Mohamed Nazari, MScClinDent

CONTACT

+60379674806; shafina.mnazari@um.edu.my

Study Design

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

Study Record Dates

• First Submitted: November 14, 2019
• First Posted: November 20, 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)