Periodontal DiseasesNCT05798871
Efficacy of Subgingival Erythritol Air Polishing in Treatment of Periodontal Pockets
A study testing Subgingival erythritol air polishing and Conventional root planing in people with Periodontal Diseases, run by University of Baghdad at 1 site in Iraq.
Trial summary
Periodontitis is an inflammation associated with destruction of the periodontium that ultimately, if not treated, leads to tooth loss. Clinically, it is characterized by clinical attachment loss (CAL) and bleeding on probing (BOP) accompanied by increased probing pocket depth (PPD) and/or gingival recession. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases
- What is being tested?
- Subgingival erythritol air polishing and Conventional root planing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteIraq
- Study dates
- 5 Mar 2023to Sep 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants should be medically healthy with periodontitis.
- Participants should have generalized periodontitis with pockets of PPD = 4 to 6 mm of any stage, unstable, and grade A to C.
- Only teeth with single root will be included.
Who cannot join
- Participants who have active cavity caries, endodontic treatment.
- Participants who have ongoing orthodontic treatment.
- Participants who have been on antibiotics within the past 4 months.
- Participants who require prophylactic antibiotic coverage.
- Participants who have been on systemic or topical non-steroidal anti- inflammatory drugs for the past 4 months.
- Participants who are pregnant or intended to and lactating mother.
- Participants who have heart valve replacement and have known intolerance or allergy to mouth rinses.
- Participants who have any systemic disease and smokers.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Erythritol Air-polishing as a Sole Treatment in the Initial Healing of Shallow Periodontal Pockets
Periodontitis is an inflammation associated with destruction of the periodontium that ultimately, if not treated, leads to tooth loss. Clinically, it is characterized by clinical attachment loss (CAL) and bleeding on probing (BOP) accompanied by increased probing pocket depth (PPD) and/or gingival recession. The standard periodontitis treatment aims to restore the homeostasis of the immune system by mechanically reducing the microbial load to levels that are compatible with stability and health. This is achieved by professional mechanical biofilm control and motivation of the patient for oral hygiene measures in order to control the biofilm and avoid disease recurrence. Conventional scaling and root planing (SRP), and air polishing therapy are tools used for professional biofilm control. More recently, air-polishing devices have become a promising alternative to conventional SRP in reducing the clinical time and causing less discomfort and pain for the patients. The objective of this study is to evaluate the efficacy of subgingival erythritol air polishing for initial periodontal pocket healing.
Read the detailed description
Periodontitis results from a polymicrobial dysbiosis with keystone pathogens affecting the virulence of the entire biofilm community. Thus, the inability of the host immune system to eliminate the biofilm insult leads to a complex chronic response with the destruction of bone and periodontal ligament attachment. The main goal of periodontal therapy is to arrest further attachment loss and, consequently, prevent further disease progression and subsequent tooth loss. In most cases, this goal can be predictably achieved by means of non-surgical periodontal therapy using hand, ultrasonic instruments and air polishing devices. Treatment with scaling and root planing often results in an additional increase of root hypersensitivity, thus impairing the patient's quality of life. Minimally invasive periodontal therapy primarily focus on calculus removal and effective removal of the biofilm rather than on excessive and intentional removal of root cementum.
Air polishing with erythritol powder seems more effective than manual instrumentation at disrupting biofilm in both shallow and deep pockets, whilst it is more gentle on the root surface and soft tissues, and allowing proper attachment of periodontal ligament fibroblasts.
Erythritol powder air-polishing with ultrasonic debridement has reported to need less time than ultrasonic debridement with polishing during periodontal therapy.Therefore, this study will evaluate the impact of erythritol air polishing in resolving periodontal pockets.
- Conditions
- Periodontal Diseases
- Being tested
- Subgingival erythritol air polishing, Conventional root planing
- Keywords
- Periodontal Disease, Air-Polishing, Air Abrasion, Periodontitis, Tooth Polishing, periodontal pockets
- Medical subject headings
- Periodontal Diseases, Periodontitis, Periodontal Pocket
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subgingival erythritol air polishingProcedure or surgery
The intervention will start with supragingival debridement followed by subgingival erythritol air polishing by perioflow.
subgingival debridement
Conventional root planingProcedure or surgery
The intervention will start with supragingival debridement followed by root planing by curette.
| Study group | Role | What they receive |
|---|---|---|
| Subgingival erythritol air polishing | Active comparator | The treatment will include the following therapy steps:
1. Supragingival debridement.
2. Subgingival erythritol air polishing by perioflow. Receives: Procedure: Subgingival erythritol air polishing |
| Conventional root planing | Active comparator | The treatment will include the following therapy steps:
1. Supragingival debridement.
2. Subgingival root planing by curette. Receives: Procedure: Conventional root planing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pocket depth
Change of pocket depth (in mm) one month after treatment
Measured: 1 month
Secondary outcomes (5)
Clinical attachment loss
Change of clinical attachment loss (in mm) one month after treatment.
Measured: 1 month
Mean relative changes in beta catenin levels in gingival crevicular fluid.
Mean relative changes in beta catenin levels in gingival crevicular fluid one month after treatment.
Measured: 1 month
Mean relative changes in 8-hydroxy-deoxyguanosine (8-OHdG) levels in gingival crevicular fluid
Mean relative changes in 8-hydroxy-deoxyguanosine (8-OHdG) levels in gingival crevicular fluid one month after treatment
Measured: 1 month
Plaque index
Change in plaque index percentage one month after treatment
Measured: 1 month
Bleeding on probing
Change in bleeding on p[robing percentage one month after treatment
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study start5 Mar 2023
- Primary completionMar 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (estimated)
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
- Mohsen K Abbass, Principal investigator, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05798871
- Sponsor's protocol ID
- 746622
- Status last verified
- Apr 2023
- First submitted
- 19 Mar 2023
- Last updated
- 5 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Aljaberi M, Abdulbaqi HR. Efficacy of Erythritol Air Polishing for Inducing Initial Healing of Shallow-to-Moderate Periodontal Pockets and Restoring Gingival Crevicular Fluid beta-Catenin, 8-Hydroxy-Deoxyguanosine and Total Antioxidant Capacity: A Split-Mouth Randomised Clinical Trial. Int J Dent Hyg. 2025 Aug;23(3):559-569. doi: 10.1111/idh.12887. Epub 2024 Dec 17.
PubMed 39686830
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Erythritol Air-polishing as a Sole Treatment in the Initial Healing of Shallow Periodontal Pockets
- ClinicalTrials.gov ID
- NCT05798871
- Acronym / sponsor ID
- 746622
- Conditions
- Periodontal Diseases
- Keywords
- Periodontal Disease, Air-Polishing, Air Abrasion, Periodontitis, Tooth Polishing, periodontal pockets
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 5 Mar 2023 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 5 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 is an inflammation associated with destruction of the periodontium that ultimately, if not treated, leads to tooth loss. Clinically, it is characterized by clinical attachment loss (CAL) and bleeding on probing (BOP) accompanied by increased probing pocket depth (PPD) and/or gingival recession. The standard periodontitis treatment aims to restore the homeostasis of the immune system by mechanically reducing the microbial load to levels that are compatible with stability and health. This is achieved by professional mechanical biofilm control and motivation of the patient for oral hygiene measures in order to control the biofilm and avoid disease recurrence. Conventional scaling and root planing (SRP), and air polishing therapy are tools used for professional biofilm control. More recently, air-polishing devices have become a promising alternative to conventional SRP in reducing the clinical time and causing less discomfort and pain for the patients. The objective of this study is to evaluate the efficacy of subgingival erythritol air polishing for initial periodontal pocket healing.
Detailed description
Periodontitis results from a polymicrobial dysbiosis with keystone pathogens affecting the virulence of the entire biofilm community. Thus, the inability of the host immune system to eliminate the biofilm insult leads to a complex chronic response with the destruction of bone and periodontal ligament attachment. The main goal of periodontal therapy is to arrest further attachment loss and, consequently, prevent further disease progression and subsequent tooth loss. In most cases, this goal can be predictably achieved by means of non-surgical periodontal therapy using hand, ultrasonic instruments and air polishing devices. Treatment with scaling and root planing often results in an additional increase of root hypersensitivity, thus impairing the patient's quality of life. Minimally invasive periodontal therapy primarily focus on calculus removal and effective removal of the biofilm rather than on excessive and intentional removal of root cementum.
Air polishing with erythritol powder seems more effective than manual instrumentation at disrupting biofilm in both shallow and deep pockets, whilst it is more gentle on the root surface and soft tissues, and allowing proper attachment of periodontal ligament fibroblasts.
Erythritol powder air-polishing with ultrasonic debridement has reported to need less time than ultrasonic debridement with polishing during periodontal therapy.Therefore, this study will evaluate the impact of erythritol air polishing in resolving periodontal pockets.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subgingival erythritol air polishing | Active comparator | Procedure: Subgingival erythritol air polishingThe treatment will include the following therapy steps: 1. Supragingival debridement. 2. Subgingival erythritol air polishing by perioflow. |
| Conventional root planing | Active comparator | Procedure: Conventional root planingThe treatment will include the following therapy steps: 1. Supragingival debridement. 2. Subgingival root planing by curette. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants should be medically healthy with periodontitis.
- Participants should have generalized periodontitis with pockets of PPD = 4 to 6 mm of any stage, unstable, and grade A to C.
- Only teeth with single root will be included.
Key exclusion criteria (8 listed)
- Participants who have active cavity caries, endodontic treatment.
- Participants who have ongoing orthodontic treatment.
- Participants who have been on antibiotics within the past 4 months.
- Participants who require prophylactic antibiotic coverage.
- Participants who have been on systemic or topical non-steroidal anti- inflammatory drugs for the past 4 months.
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 |
|---|---|---|
| Subgingival erythritol air polishingThe intervention will start with supragingival debridement followed by subgingival erythritol air polishing by perioflow. subgingival debridement | Procedure or surgery | Subgingival erythritol air polishing |
| Conventional root planingThe intervention will start with supragingival debridement followed by root planing by curette. | Procedure or surgery | Conventional root planing |
Primary outcome
Pocket depth
Time frame: 1 month
Change of pocket depth (in mm) one month after treatment
5 secondary outcomes
Clinical attachment loss
Time frame: 1 month
Mean relative changes in beta catenin levels in gingival crevicular fluid.
Time frame: 1 month
Mean relative changes in 8-hydroxy-deoxyguanosine (8-OHdG) levels in gingival crevicular fluid
Time frame: 1 month
Plaque index
Time frame: 1 month
Bleeding on probing
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2023.
- Derived from this study: PubMed 39686830Aljaberi M, Abdulbaqi HR. Efficacy of Erythritol Air Polishing for Inducing Initial Healing of Shallow-to-Moderate Periodontal Pockets and Restoring Gingival Crevicular Fluid beta-Catenin, 8-Hydroxy-Deoxyguanosine and Total Antioxidant Capacity: A Split-Mouth Randomised Clinical Trial. Int J Dent Hyg. 2025 Aug;23(3):559-569. doi: 10.1111/idh.12887. Epub 2024 Dec 17.
- Individual participant dataSharing planned: Undecided
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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.
Mohsen K Abbass 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 Subgingival erythritol air polishing and Conventional root planing 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 3 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 5 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?
Pocket depth (time frame: 1 month). 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 NCT05798871, which also lists 1 linked publication.
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 5 Apr 2023.