Periodontal DiseasesNCT05812391
Impact of Full Mouth Erythritol Powder Air Polishing on Systemic Inflammatory Response
A study testing test and conventional in people with Periodontal Diseases, run by University of Baghdad at 1 site in Iraq.
Trial summary
Periodontitis (PD) is an inflammatory condition that affects 20%-50% of the total global population, with severe disease occurring in 9.8% of individuals. clinically characterized by clinical attachment loss (CAL) and bleeding on probing (BOP) accompanied by increased probing pocket depth (PPD) and/or gingival… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases
- What is being tested?
- test and conventional
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteIraq
- Study dates
- 10 Mar 2023to Oct 2024
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants who have periodontitis, unstable, at any stage
Who cannot join
- Participants who are known or suspected high risk for tuberculosis
- Participants who have hepatitis B or HIV infections
- Participants who are being unable to provide written, informed consent
- Participants who have history of bleeding diathesis
- Participants who are pregnant or intended to and lactating mother.
- Participants who are self-reported diagnosis of any systemic illnesses including cardiovascular, renal and liver diseases
- Participants who have regular use of medication to control systemic illness.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Systemic Inflammatory Response Following Full Mouth Erythritol Powder Air Polishing and Instrumentation: A Randomized Clinical Trial
Periodontitis (PD) is an inflammatory condition that affects 20%-50% of the total global population, with severe disease occurring in 9.8% of individuals. clinically characterized by clinical attachment loss (CAL) and bleeding on probing (BOP) accompanied by increased probing pocket depth (PPD) and/or gingival recession, it may end with tooth loss if left untreated. non-surgical periodontal treatment (NSPT) represents the first line of treatment and involves the physical debridement of subgingival plaque biofilms. "full-mouth debridement" (FMD) approach, its NSPT delivers complete debridement within 24 hr. However, full-mouth NSPT has been consistently shown to trigger a large systemic inflammatory response 24 hr following treatment. Nevertheless, Interestingly, a positive correlation between treatment time and the subsequent systemic inflammatory response has been reported. Given this previous link and the different features of each instrumentation technique including air-polishing devices (APDs), that have less time-consuming treatment, reduce patient discomfort and sensitivity, and only minor alterations to surrounding soft and hard tissues. This study aims to evaluate the systemic inflammatory response following full-mouth erythritol powder air polishing and instrumentation.
Read the detailed description
Periodontitis is a common chronic inflammatory disease caused by specific oral dysbiosis and characterized by a progressive loss of soft and hard tissues keeping the teeth. if left untreated, it leads not only to tooth loss, negative influences on the patient's quality of life and masticatory impairment may happen. There is significant evidence of clinical improvements in PD patients following non-surgical periodontal treatment (NSPT), including gains in clinical attachment level, reductions in gingival inflammation, and reduced periodontal pocket depths.
A conventional Full-mouth hand debridement has been consistently shown to trigger a large systemic inflammatory mediator, The reasons for such a response may be related to both the transient post-operative bacteremia and the extension of the operative trauma.
a recent joint consensus statement advised against full-mouth debridement for some medically compromised patients.
The erythritol powder is a water-soluble, non-toxic sugar alcohol and artificial sweetener, has a mean particle size of 14 μm, and can be used for supra and subgingival removal of biofilm and stains.
It has also been suggested that teeth with sites of furcation involvement and/or with reduced access, which have traditionally been difficult to debride with conventional instrumentation, may benefit from air-flow therapy
Comparing full-mouth ultrasonic debridement with polishing paste and full-mouth erythritol powder air polishing followed by ultrasonic debridement. this study hypothesized that the later procedure may reduce the extent of systemic inflammatory mediators they induce by removing the biofilm before the conventional full-mouth (supra and sub-gingival) ultrasonic debridement.
- Conditions
- Periodontal Diseases
- Being tested
- test, conventional
- Keywords
- Periodontal disease, Periodontitis, Air abrasion, Tooth polishing, Air-polishing
- Medical subject headings
- Periodontal Diseases, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
testProcedure or surgery
the treatment start with supra-gingival erythritol powerder air polishing followed by sub-gingival erythritol powerder air polishing,supra-gingival debridement and sub-gingival debridement
conventionalProcedure or surgery
the treatment start with supra-gingival debridement followed by sub-gingival debridement then finished with polishing paste
| Study group | Role | What they receive |
|---|---|---|
| test group | Active comparator | Supra-gingival erythritol powerder air polishing Sub-gingival erythritol powerder air polishing Supra-gingival debridement Sub-gingival debridement Receives: Procedure: test |
| conventional group | Active comparator | Supra-gingival debridement Sub-gingival debridement Polishing with polishing paste Receives: Procedure: conventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum level of C-reactive protein
Change in serum level of C-reactive protein 24 hours following the full mouth debridement
Measured: 24 hours
Secondary outcomes (5)
Treatment time
Evaluate the effect of treatment time (minute) on clinical parameters after 30 days
Measured: 30 days
Change in percentage of bleeding on probing
Change in the percentage of bleeding on probing 30 days after treatment
Measured: 30 days
Change in mean probing pocket depth
Change in mean probing pocket depth (mm) 30 days after treatment
Measured: 30 days
Change in clinical attachment loss
Change in clinical attachment loss (mm)30 days after treatment
Measured: 30 days
Change in percentage of plaque index
Change in percentage of plaque index 30 days after treatment
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2023
- Study start10 Mar 2023
- Primary completionMar 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- More trials run by University of BaghdadThe 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hayder Raad Abdulbaqi, University of Baghdad
- Investigators
- Mohammed K Ayoob, Principal investigator, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05812391
- Sponsor's protocol ID
- 745622
- Status last verified
- Apr 2023
- First submitted
- 2 Apr 2023
- Last updated
- 19 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systemic Inflammatory Response Following Full Mouth Erythritol Powder Air Polishing and Instrumentation: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05812391
- Acronym / sponsor ID
- 745622
- Conditions
- Periodontal Diseases
- Keywords
- Periodontal disease, Periodontitis, Air abrasion, Tooth polishing, Air-polishing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 10 Mar 2023 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 13 Apr 2023 (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.
Periodontitis (PD) is an inflammatory condition that affects 20%-50% of the total global population, with severe disease occurring in 9.8% of individuals. clinically characterized by clinical attachment loss (CAL) and bleeding on probing (BOP) accompanied by increased probing pocket depth (PPD) and/or gingival recession, it may end with tooth loss if left untreated. non-surgical periodontal treatment (NSPT) represents the first line of treatment and involves the physical debridement of subgingival plaque biofilms. "full-mouth debridement" (FMD) approach, its NSPT delivers complete debridement within 24 hr. However, full-mouth NSPT has been consistently shown to trigger a large systemic inflammatory response 24 hr following treatment. Nevertheless, Interestingly, a positive correlation between treatment time and the subsequent systemic inflammatory response has been reported. Given this previous link and the different features of each instrumentation technique including air-polishing devices (APDs), that have less time-consuming treatment, reduce patient discomfort and sensitivity, and only minor alterations to surrounding soft and hard tissues. This study aims to evaluate the systemic inflammatory response following full-mouth erythritol powder air polishing and instrumentation.
Detailed description
Periodontitis is a common chronic inflammatory disease caused by specific oral dysbiosis and characterized by a progressive loss of soft and hard tissues keeping the teeth. if left untreated, it leads not only to tooth loss, negative influences on the patient's quality of life and masticatory impairment may happen. There is significant evidence of clinical improvements in PD patients following non-surgical periodontal treatment (NSPT), including gains in clinical attachment level, reductions in gingival inflammation, and reduced periodontal pocket depths.
A conventional Full-mouth hand debridement has been consistently shown to trigger a large systemic inflammatory mediator, The reasons for such a response may be related to both the transient post-operative bacteremia and the extension of the operative trauma.
a recent joint consensus statement advised against full-mouth debridement for some medically compromised patients.
The erythritol powder is a water-soluble, non-toxic sugar alcohol and artificial sweetener, has a mean particle size of 14 μm, and can be used for supra and subgingival removal of biofilm and stains.
It has also been suggested that teeth with sites of furcation involvement and/or with reduced access, which have traditionally been difficult to debride with conventional instrumentation, may benefit from air-flow therapy
Comparing full-mouth ultrasonic debridement with polishing paste and full-mouth erythritol powder air polishing followed by ultrasonic debridement. this study hypothesized that the later procedure may reduce the extent of systemic inflammatory mediators they induce by removing the biofilm before the conventional full-mouth (supra and sub-gingival) ultrasonic debridement.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| test group | Active comparator | Procedure: testSupra-gingival erythritol powerder air polishing Sub-gingival erythritol powerder air polishing Supra-gingival debridement Sub-gingival debridement |
| conventional group | Active comparator | Procedure: conventionalSupra-gingival debridement Sub-gingival debridement Polishing with polishing paste |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants who have periodontitis, unstable, at any stage
Key exclusion criteria (7 listed)
- Participants who are known or suspected high risk for tuberculosis
- Participants who have hepatitis B or HIV infections
- Participants who are being unable to provide written, informed consent
- Participants who have history of bleeding diathesis
- Participants who are pregnant or intended to and lactating mother.
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 |
|---|---|---|
| testthe treatment start with supra-gingival erythritol powerder air polishing followed by sub-gingival erythritol powerder air polishing,supra-gingival debridement and sub-gingival debridement | Procedure or surgery | test group |
| conventionalthe treatment start with supra-gingival debridement followed by sub-gingival debridement then finished with polishing paste | Procedure or surgery | conventional group |
Primary outcome
Change in serum level of C-reactive protein
Time frame: 24 hours
Change in serum level of C-reactive protein 24 hours following the full mouth debridement
5 secondary outcomes
Treatment time
Time frame: 30 days
Change in percentage of bleeding on probing
Time frame: 30 days
Change in mean probing pocket depth
Time frame: 30 days
Change in clinical attachment loss
Time frame: 30 days
Change in percentage of plaque index
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2023.
- 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.
Mohammed K Ayoob principal investigator
University of Baghdad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing test and conventional in people with Periodontal Diseases, run by University of Baghdad at 1 site in Iraq.
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 1 inclusion and 7 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 19 Apr 2023. 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 Iraq. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum level of C-reactive protein (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Apr 2023.