PeriodontitisGBTNCT06726902
Comparative Evaluation of the Effect of Different Adjunctive Air Polishing Powders in Nonsurgical Periodontal Therapy in Patients with Stage II and III Periodontitis
A study testing GBT and SI with erythritol powder, GBT and SI with glycine powder and GBT and SI with trehalose powder in people with Periodontitis, run by Diana Ibrahim at 1 site in Egypt.
Trial summary
The aim of this clinical trial is to evaluate and compare the effect of a newly designed air-polishing device (APD) using Erythritol, Glycine, and Trehalose air-polishing powders in nonsurgical periodontal therapy with control (conventional scaling and root planning) following the concept of guided biofilm therapy… Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Periodontitis
- What is being tested?
- GBT and SI with erythritol powder, GBT and SI with glycine powder and GBT and SI with trehalose powder
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Mar 2024to Dec 2024
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals of both sexes with an age between 30 and 65 years, having at least 16 natural teeth in function,
- Stage II and III (moderate to severe) periodontitis, having at least 16 teeth with the need for SI
- Interproximal plaque index (API) ≤ 35%; patients with Good oral hygiene.
- No history of systemic disease that may influence periodontal disease
Who cannot join
- Pregnancy or breastfeeding,
- Smokers with more than seven cigarettes per day
- Patients that had a treatment with antibiotics within six months before the study
- Need for periodontal surgery or adjunctive antibiotic treatment to the SI
- Patients who had any periodontal treatment during the last year before the study.
- Patients with known systemic or autoimmune disease.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparative Evaluation of the Effect of Different Adjunctive Air Polishing Powders in Nonsurgical Periodontal Therapy in Patients with Stage II and III Periodontitis: (A Randomized Controlled Clinical Trial)
The aim of this clinical trial is to evaluate and compare the effect of a newly designed air-polishing device (APD) using Erythritol, Glycine, and Trehalose air-polishing powders in nonsurgical periodontal therapy with control (conventional scaling and root planning) following the concept of guided biofilm therapy (GBT) as an adjunctive to subgingival instrumentation (SI) in nonsurgical periodontal therapy for Stage II and III periodontitis patients both clinically and microbiologically.
- Conditions
- Periodontitis
- Being tested
- GBT and SI with erythritol powder, GBT and SI with glycine powder, GBT and SI with trehalose powder, SRP and SI
- Keywords
- GBT, Periodontitis, SI
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GBT and SI with erythritol powderDevice
Also called guided biofilm therapy
Non-Surgical Periodontal treatment:
- Guided Biofilm Therapy
- Guided supragingival and shallow subgingival (PD ≥ 4 mm) removal of biofilm and stains from all quadrants using the air-polishing device using a standard nozzle system.
- Subgingival removal of biofilm from deeper periodontal pockets (PD ≥ 6 mm) using an Air-polishing device subgingival nozzle system with erythritol powder .
- Scaling and root planing Scaling and root planing (SRP) For the control group, conventional scaling and root planning (SRP) only.
GBT and SI with glycine powderOther
Non-Surgical Periodontal treatment:
- Guided Biofilm Therapy • Guided supragingival and shallow subgingival (PD ≥ 4 mm) removal of biofilm and stains from all quadrants using the air-polishing device using a standard nozzle system. • Subgingival removal of biofilm from deeper periodontal pockets (PD ≥ 6 mm) using an Air-polishing device subgingival nozzle system with glycine powder.
- Scaling and root planing Scaling and root planing (SRP) For the control group, conventional scaling and root planning (SRP) only
GBT and SI with trehalose powderOther
Non-Surgical Periodontal treatment:
- Guided Biofilm Therapy • Guided supragingival and shallow subgingival (PD ≥ 4 mm) removal of biofilm and stains from all quadrants using the air-polishing device using a standard nozzle system. • Subgingival removal of biofilm from deeper periodontal pockets (PD ≥ 6 mm) using an Air-polishing device subgingival nozzle system with trehalose powder .
- Scaling and root planing Scaling and root planing (SRP) For the control group, conventional scaling and root planning (SRP) only
SRP and SIOther
conventional scaling and root planning (SRP) with subgingival instrumentation only will be performed
| Study group | Role | What they receive |
|---|---|---|
| Test Group I (GBT and SI + erythritol powder) | Experimental | will receive GBT and SI with adjunctive air-polishing using Standard/ Subgingival nozzle + erythritol powder Receives: Device: GBT and SI with erythritol powder |
| Test Group II (GBT and SI + glycine powder) | Experimental | will receive GBT and SI with adjunctive air-polishing using Standard/ Subgingival nozzle + glycine powder Receives: Other: GBT and SI with glycine powder |
| Test Group III (GBT and SI + Trehalose powder) | Experimental | will receive GBT and SI with adjunctive air-polishing using Standard/ Subgingival nozzle + Trehalose powder Receives: Other: GBT and SI with trehalose powder |
| Control Group VI (SRP and SI) | Experimental | will receive conventional Scaling and Root planning (SRP) and (SI) without adjunctive air polishing powder Receives: Other: SRP and SI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding on probing
Measured: up to six months
Pain Assessment
Pain level will be assed using Visual Analogue Scale (VAS) from 1 (minimum) to 10 (maximum)
Measured: up to six months
Probing depth
Measured: up to six months
Plaque accumulation
Measured: up to six months
Clinical attachment level
Measured: up to six months
Microbiological Assessment of Aggregatibacter actinomycetemcomitans (Aa)
Measured: one month
Microbiological Assessment of Porphyromonas gingivalis (Pg)
Measured: one month
Microbiological Assessment of Tannerella forsythia (Tf)
Measured: one month
Microbiological Assessment of Treponema denticola (Td)
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start3 Mar 2024
- Primary completion1 Nov 2024
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diana Ibrahim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Diana Ibrahim, Alexandria University
- Investigators
- Rania Abdelaziz Fahmy, PhD, Study director, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06726902
- Sponsor's protocol ID
- IORG 0008839-0854-01/2024
- Acronym
- GBT
- Status last verified
- Dec 2024
- First submitted
- 6 Dec 2024
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of the Effect of Different Adjunctive Air Polishing Powders in Nonsurgical Periodontal Therapy in Patients with Stage II and III Periodontitis: (A Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT06726902
- Acronym / sponsor ID
- GBT / IORG 0008839-0854-01/2024
- Conditions
- Periodontitis
- Keywords
- GBT, Periodontitis, SI
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Diana IbrahimUniversity, hospital or other
- Study start
- 3 Mar 2024 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- Dec 2024 (estimated)
- First posted
- 10 Dec 2024 (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.
The aim of this clinical trial is to evaluate and compare the effect of a newly designed air-polishing device (APD) using Erythritol, Glycine, and Trehalose air-polishing powders in nonsurgical periodontal therapy with control (conventional scaling and root planning) following the concept of guided biofilm therapy (GBT) as an adjunctive to subgingival instrumentation (SI) in nonsurgical periodontal therapy for Stage II and III periodontitis patients both clinically and microbiologically.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Test Group I (GBT and SI + erythritol powder) | Experimental | Device: GBT and SI with erythritol powderwill receive GBT and SI with adjunctive air-polishing using Standard/ Subgingival nozzle + erythritol powder |
| Test Group II (GBT and SI + glycine powder) | Experimental | Other: GBT and SI with glycine powderwill receive GBT and SI with adjunctive air-polishing using Standard/ Subgingival nozzle + glycine powder |
| Test Group III (GBT and SI + Trehalose powder) | Experimental | Other: GBT and SI with trehalose powderwill receive GBT and SI with adjunctive air-polishing using Standard/ Subgingival nozzle + Trehalose powder |
| Control Group VI (SRP and SI) | Experimental | Other: SRP and SIwill receive conventional Scaling and Root planning (SRP) and (SI) without adjunctive air polishing powder |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Individuals of both sexes with an age between 30 and 65 years, having at least 16 natural teeth in function,
- Stage II and III (moderate to severe) periodontitis, having at least 16 teeth with the need for SI
- Interproximal plaque index (API) ≤ 35%; patients with Good oral hygiene.
- No history of systemic disease that may influence periodontal disease
Key exclusion criteria (6 listed)
- Pregnancy or breastfeeding,
- Smokers with more than seven cigarettes per day
- Patients that had a treatment with antibiotics within six months before the study
- Need for periodontal surgery or adjunctive antibiotic treatment to the SI
- Patients who had any periodontal treatment during the last year before the study.
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 |
|---|---|---|
| GBT and SI with erythritol powderAlso: guided biofilm therapyNon-Surgical Periodontal treatment: 1. Guided Biofilm Therapy * Guided supragingival and shallow subgingival (PD ≥ 4 mm) removal of biofilm and stains from all quadrants using the air-polishing device using a standard nozzle system. * Subgingival removal of biofilm from deeper periodontal pockets (PD ≥ 6 mm) using an Air-polishing device subgingival nozzle system with erythritol powder . 2. Scaling and root planing Scaling and root planing (SRP) For the control group, conventional scaling and root planning (SRP) only. | Device | Test Group I (GBT and SI + erythritol powder) |
| GBT and SI with glycine powderNon-Surgical Periodontal treatment: 1. Guided Biofilm Therapy • Guided supragingival and shallow subgingival (PD ≥ 4 mm) removal of biofilm and stains from all quadrants using the air-polishing device using a standard nozzle system. • Subgingival removal of biofilm from deeper periodontal pockets (PD ≥ 6 mm) using an Air-polishing device subgingival nozzle system with glycine powder. 2. Scaling and root planing Scaling and root planing (SRP) For the control group, conventional scaling and root planning (SRP) only | Other | Test Group II (GBT and SI + glycine powder) |
| GBT and SI with trehalose powderNon-Surgical Periodontal treatment: 1. Guided Biofilm Therapy • Guided supragingival and shallow subgingival (PD ≥ 4 mm) removal of biofilm and stains from all quadrants using the air-polishing device using a standard nozzle system. • Subgingival removal of biofilm from deeper periodontal pockets (PD ≥ 6 mm) using an Air-polishing device subgingival nozzle system with trehalose powder . 2. Scaling and root planing Scaling and root planing (SRP) For the control group, conventional scaling and root planning (SRP) only | Other | Test Group III (GBT and SI + Trehalose powder) |
| SRP and SIconventional scaling and root planning (SRP) with subgingival instrumentation only will be performed | Other | Control Group VI (SRP and SI) |
Primary outcome
Bleeding on probing
Time frame: up to six months
Pain Assessment
Time frame: up to six months
Pain level will be assed using Visual Analogue Scale (VAS) from 1 (minimum) to 10 (maximum)
Probing depth
Time frame: up to six months
Plaque accumulation
Time frame: up to six months
Clinical attachment level
Time frame: up to six months
Microbiological Assessment of Aggregatibacter actinomycetemcomitans (Aa)
Time frame: one month
Microbiological Assessment of Porphyromonas gingivalis (Pg)
Time frame: one month
Microbiological Assessment of Tannerella forsythia (Tf)
Time frame: one month
Microbiological Assessment of Treponema denticola (Td)
Time frame: one month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Individual participant dataSharing planned: Yes
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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.
Rania Abdelaziz Fahmy, PhD study director
Alexandria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GBT and SI with erythritol powder, GBT and SI with glycine powder and GBT and SI with trehalose powder in people with Periodontitis, run by Diana Ibrahim at 1 site in Egypt.
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 4 inclusion and 6 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: enrolling by invitation, as of the sponsor's last update on 12 Dec 2024. 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
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?
Bleeding on probing (time frame: up to six months). The study lists 9 primary outcomes in all. 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 12 Dec 2024.