PeriodontitisNCT04169945
Compare Air Polishing With Ultrasonic During Maintenance
A study testing Ultrasonic instrumentation and Air polishing with erythritol powder in people with Periodontitis, run by University of Malaya at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- What is being tested?
- Ultrasonic instrumentation and Air polishing with erythritol powder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteMalaysia
- Study dates
- 31 Jan 2020to Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Malaysia1 site, 1 recruiting
- Recruiting
Faculty of Dentistry
Kuala Lumpur, 50603
Nor Adinar Baharuddin, DClinDent, 0196935088, noradinar@um.edu.my
About this study
Official title: Subgingival Debridement by Erythritol Powder Air-Polishing (EPAP) in Comparison With Ultrasonic Instrumentation During Periodontal Maintenance. A Randomised Clinical Trial
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.
Read the detailed description
As a result of ongoing microbiological challenge from accumulated dental plaque, it is paramount to ensure thorough removal of such deposits from the root surface to maintain periodontal health. Mechanical instrumentation using conventional hand instrument and/or oscillating scalers is the gold standard of periodontal therapy. Patient is commonly recalled every 3-4 months interval for supportive periodontal therapy (SPT) to decrease disease recurrence and prevent further tooth loss. This repeated mechanical instrumentation, however, may cause irreversible damage to dental hard tissue. As such, the use of treatment modalities effective in removing biofilm, being time efficient, causing minimal discomfort, tissue damage, and less abrasion of root surface would be preferable during SPT.
With the advancement of technology in dentistry, air polishing (AP) was introduced to dentistry for cavity reparation in 1945. The usage then extended into periodontal debridement in SPT, by means of slurry pressurized air with a novel low abrasive powder and water. A study done by Petersilka et al. 2003 in 27 SPT patients of pockets 3-5mm depth revealed an approximately 90% reduction in all viable bacterial counts and offered greater patient comfort when compared to conventional hand instrument. It was also time saving as only 5 seconds is needed per tooth surface. Since 1980s, sodium bicarbonate has been used in AP devices and was the only powder available until 2004. It is non-toxic, water-soluble, safe for intra-oral use and is efficient in removing biofilm and staining on intact enamel surfaces. However, this conventional powder can cause substantial damage to the root cementum and dentine at area of receded gingiva, severe epithelial erosion and unpleasant perception by patients.
In order to deal with this issue, several types of AP abrasive powders with improved clinical performance and patient comfort have been produced. As early as in 2003, glycine based (amino acid) powders were produced with smaller mean particle size 45-60 µm and less chiseled shape, compared to sharp edged and up to 250 µm mean particle size of sodium bicarbonate. Due to its ≈80% less abrasiveness, studies had shown that glycine powder air-polishing (GPAP) was more efficient in plaque removal in root debridement, caused non-critical substance loss and lower the rate of increase in root surface roughness when compared to sodium bicarbonate. On the other hand, in a publication by Flemmig et al. in 2007, efficacy of GPAP was assessed in periodontal pockets of various depths. The results revealed the average debridement depth of 2mm was obtained at pockets depth of 4mm, and 60% of subgingival root surface was cleaned. In deeper pockets, the efficacy reduced to about 40% and the use of hand instruments or ultrasonic scalers may be superior.
Thus, Moёne et al. had described a newly designed nozzle in 2010 in order to extend the use of air polishing in deeper pockets. This nozzle allowed access to subgingival root surfaces and the jet spray has a lower flow and pressure compared to supragingivally applied air polishing. This new device appeared to be safe, perceived to be more acceptable by patients and was more time efficient than scaling and root planing. However, Petersilka (2010) pointed out two cases of air emphysema developed after using this jet system but fortunately the cases resolved within 4 days without additional intervention. Therefore, he remarked that emphysema cannot be completely ruled out in all other types of air-polishing systems. Since then, more studies have been carried out using this newly designed nozzle with GPAP. A 2-months trial by Wennstrӧm et al. in 20 recall patients showed no significant differences in clinical or microbiological outcomes between subgingivally applied GPAP (SubGPAP) and ultrasonic debridement of moderate deep pockets (5-8mm). They also noted there was only a short-term reduction of subgingival microflora in both modalities.
Recently, a natural sugar erythritol powder has gained its popularity as it has slightly lower abrasiveness and smaller particle size 14-31 µm compared to glycine. In 2013, Hashino et al. found that erythritol has inhibitory effect on the biofilm produced by Streptococcus gordonii and Porphyromonas gingivalis. A year after, Drago and team tested on a new formulation consisting of erythritol and chlorhexidine with the standard glycine powder. This in vitro study demonstrated that the combination of erythritol/chlorhexidine displayed a stronger antimicrobial and antibiofilm activity on titanium discs. While in a 12 months clinical trial by Müller and co-workers, repeated subgingival air polishing with erythritol containing 0.3% chlorhexidine appeared to be safe, reduced the number of pockets >4mm and induced less pain than ultrasonic instrumentation. As subgingival biofilm may not mineralise between two SPT visits, less aggressive approach with better microbiological outcome may be appropriate for residual pockets.
Based on the available literature, requirements like time efficiency, minimal hard and soft tissue damage, along with high patient acceptance and safety, are important for repeated treatments especially in SPT. Whether a new air-polishing powder, used with a specially designed nozzle may be a valid alternative to conventional debridement, cost efficiency is another essential aspect to be defined. As periodontitis patients need long-term professional care and in the light of rising healthcare costs, a cost- and clinically effective treatment modality is required.
- Conditions
- Periodontitis
- Being tested
- Ultrasonic instrumentation, Air polishing with erythritol powder
- Keywords
- periodontitis, air polishing, randomised clinical trial, debridement
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonic instrumentationOther
Full mouth root surface debridement
Air polishing with erythritol powderOther
Air flow PLUS
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: Ultrasonic instrumentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of pocket depth >4mm
To determine presence of pocket depth > 4 mm after 6 months
Measured: 6 months
Secondary outcomes (4)
Clinical attachment level gain (CAL)
To determine presence of CAL after 6 months
Measured: 6 months
Patient reported outcome measures (PROM)
Patient reported outcome measures using visual analogue scales score where 0 is no pain and 10 is the worst pain
Measured: 6 months
Incremental Cost Effectiveness Ratio (ICER)
Incremental Cost Effectiveness Ratio
Measured: 6 months
Patient reported outcome measures (PROM)
Patient reported outcome measures using oral health impact profile (OHIP-14) score, based on the likert scale responses; which were coded as (1) very often, (2) quite often, (3) sometimes, (4) seldom, (5) never and (6) don't know.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2019
- Study start31 Jan 2020
- Primary completionJan 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nor Adinar Baharuddin, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04169945
- Sponsor's protocol ID
- 101269-3
- Status last verified
- Feb 2020
- First submitted
- 14 Nov 2019
- Last updated
- 7 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25060742Flemmig 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.
PubMed 9495615Hashino 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.
PubMed 23890177Mohd-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.
PubMed 29702916Petersilka 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.
PubMed 12622860Sahrmann 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.
PubMed 24476548Wennstrom 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.
PubMed 21736599Zappa 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.
PubMed 1765938Buhler 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.
PubMed 25240922Farooqi 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.
PubMed 26698003Flemmig 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.
PubMed 17539712Lindhe 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.
PubMed 6384275Lindhe 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.
PubMed 6378986Moene 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.
PubMed 20059420Muller 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.
PubMed 25041441
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subgingival Debridement by Erythritol Powder Air-Polishing (EPAP) in Comparison With Ultrasonic Instrumentation During Periodontal Maintenance. A Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT04169945
- Acronym / sponsor ID
- 101269-3
- Conditions
- Periodontitis
- Keywords
- periodontitis, air polishing, randomised clinical trial, debridement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 31 Jan 2020 (actual)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 20 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
As a result of ongoing microbiological challenge from accumulated dental plaque, it is paramount to ensure thorough removal of such deposits from the root surface to maintain periodontal health. Mechanical instrumentation using conventional hand instrument and/or oscillating scalers is the gold standard of periodontal therapy. Patient is commonly recalled every 3-4 months interval for supportive periodontal therapy (SPT) to decrease disease recurrence and prevent further tooth loss. This repeated mechanical instrumentation, however, may cause irreversible damage to dental hard tissue. As such, the use of treatment modalities effective in removing biofilm, being time efficient, causing minimal discomfort, tissue damage, and less abrasion of root surface would be preferable during SPT.
With the advancement of technology in dentistry, air polishing (AP) was introduced to dentistry for cavity reparation in 1945. The usage then extended into periodontal debridement in SPT, by means of slurry pressurized air with a novel low abrasive powder and water. A study done by Petersilka et al. 2003 in 27 SPT patients of pockets 3-5mm depth revealed an approximately 90% reduction in all viable bacterial counts and offered greater patient comfort when compared to conventional hand instrument. It was also time saving as only 5 seconds is needed per tooth surface. Since 1980s, sodium bicarbonate has been used in AP devices and was the only powder available until 2004. It is non-toxic, water-soluble, safe for intra-oral use and is efficient in removing biofilm and staining on intact enamel surfaces. However, this conventional powder can cause substantial damage to the root cementum and dentine at area of receded gingiva, severe epithelial erosion and unpleasant perception by patients.
In order to deal with this issue, several types of AP abrasive powders with improved clinical performance and patient comfort have been produced. As early as in 2003, glycine based (amino acid) powders were produced with smaller mean particle size 45-60 µm and less chiseled shape, compared to sharp edged and up to 250 µm mean particle size of sodium bicarbonate. Due to its ≈80% less abrasiveness, studies had shown that glycine powder air-polishing (GPAP) was more efficient in plaque removal in root debridement, caused non-critical substance loss and lower the rate of increase in root surface roughness when compared to sodium bicarbonate. On the other hand, in a publication by Flemmig et al. in 2007, efficacy of GPAP was assessed in periodontal pockets of various depths. The results revealed the average debridement depth of 2mm was obtained at pockets depth of 4mm, and 60% of subgingival root surface was cleaned. In deeper pockets, the efficacy reduced to about 40% and the use of hand instruments or ultrasonic scalers may be superior.
Thus, Moёne et al. had described a newly designed nozzle in 2010 in order to extend the use of air polishing in deeper pockets. This nozzle allowed access to subgingival root surfaces and the jet spray has a lower flow and pressure compared to supragingivally applied air polishing. This new device appeared to be safe, perceived to be more acceptable by patients and was more time efficient than scaling and root planing. However, Petersilka (2010) pointed out two cases of air emphysema developed after using this jet system but fortunately the cases resolved within 4 days without additional intervention. Therefore, he remarked that emphysema cannot be completely ruled out in all other types of air-polishing systems. Since then, more studies have been carried out using this newly designed nozzle with GPAP. A 2-months trial by Wennstrӧm et al. in 20 recall patients showed no significant differences in clinical or microbiological outcomes between subgingivally applied GPAP (SubGPAP) and ultrasonic debridement of moderate deep pockets (5-8mm). They also noted there was only a short-term reduction of subgingival microflora in both modalities.
Recently, a natural sugar erythritol powder has gained its popularity as it has slightly lower abrasiveness and smaller particle size 14-31 µm compared to glycine. In 2013, Hashino et al. found that erythritol has inhibitory effect on the biofilm produced by Streptococcus gordonii and Porphyromonas gingivalis. A year after, Drago and team tested on a new formulation consisting of erythritol and chlorhexidine with the standard glycine powder. This in vitro study demonstrated that the combination of erythritol/chlorhexidine displayed a stronger antimicrobial and antibiofilm activity on titanium discs. While in a 12 months clinical trial by Müller and co-workers, repeated subgingival air polishing with erythritol containing 0.3% chlorhexidine appeared to be safe, reduced the number of pockets >4mm and induced less pain than ultrasonic instrumentation. As subgingival biofilm may not mineralise between two SPT visits, less aggressive approach with better microbiological outcome may be appropriate for residual pockets.
Based on the available literature, requirements like time efficiency, minimal hard and soft tissue damage, along with high patient acceptance and safety, are important for repeated treatments especially in SPT. Whether a new air-polishing powder, used with a specially designed nozzle may be a valid alternative to conventional debridement, cost efficiency is another essential aspect to be defined. As periodontitis patients need long-term professional care and in the light of rising healthcare costs, a cost- and clinically effective treatment modality is required.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasonic instrumentation and Air Polishing | Experimental | Other: Ultrasonic instrumentation, Other: Air polishing with erythritol powderAll 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 |
| Ultrasonic instrumentation | Active comparator | Other: Ultrasonic instrumentationAll participants will receive full mouth conventional ultrasonic subgingival debridement only. No time limit (Flemmig 2012), until dental surfaces feel smooth. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasonic instrumentationFull mouth root surface debridement | Other | Ultrasonic instrumentation, Ultrasonic instrumentation and Air Polishing |
| Air polishing with erythritol powderAir flow PLUS | Other | Ultrasonic instrumentation and Air Polishing |
Primary outcome
Presence of pocket depth >4mm
Time frame: 6 months
To determine presence of pocket depth > 4 mm after 6 months
4 secondary outcomes
Clinical attachment level gain (CAL)
Time frame: 6 months
Patient reported outcome measures (PROM)
Time frame: 6 months
Incremental Cost Effectiveness Ratio (ICER)
Time frame: 6 months
Patient reported outcome measures (PROM)
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2020.
- Background: PubMed 25060742Drago 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.
- Background: PubMed 9495615Flemmig 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.
- Background: PubMed 23890177Hashino 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.
- Background: PubMed 29702916Mohd-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.
- Background: PubMed 12622860Petersilka 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.
- Background: PubMed 24476548Sahrmann 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.
- Background: PubMed 21736599Wennstrom 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.
- Background: PubMed 1765938Zappa 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.
- Results publication: PubMed 25240922Buhler 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.
- Results publication: PubMed 26698003Farooqi 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.
- Results publication: PubMed 17539712Flemmig 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.
- Results publication: PubMed 6384275Lindhe 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasonic instrumentation and Air polishing with erythritol powder in people with Periodontitis, run by University of Malaya at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nor Adinar Baharuddin, DClinDent (0196935088, noradinar@um.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of pocket depth >4mm (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04169945, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2020.