Periodontal PocketNCT06351982
Treatment Of Shallow Periodontal Pockets 4-6mm Using AIRFLOW Prophylaxis Master Device With Erythritol vs Manual Scalers
A study testing Electro Medical Systems AIRFLOW® Prophylaxis Master Device and Hand and ultrasonic scalers and curettes in people with Periodontal Pocket and Periodontitis, run by Cairo University at 1 site in Egypt.
Trial summary
Periodontitis is a chronic condition associated with the inflammatory destruction of the periodontal tissues ultimately leading to tooth loss. Clinically, it is identified by key features such as clinical attachment loss (CAL), bleeding upon probing (BOP), and an increase in probing pocket depth (PPD), and/or gingival… Read more about this study
- Who is it for?
- Ages 16 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Pocket, Periodontitis, Gingival Diseases
- What is being tested?
- Electro Medical Systems AIRFLOW® Prophylaxis Master Device and Hand and ultrasonic scalers and curettes
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2024to 1 Jan 2026
- 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 16 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Systemically healthy patients.
- Patients with an age range between 16 to 80 years.
- Patients have a minimum of 20 teeth.
- Periodontitis patients with at least one residual pocket with a probing depth ranging from 4 to 6 mm.
- Cooperative patients able and willing to come for follow up appointments.
Who cannot join
- Pregnant and lactation females.
- Patients reporting systemic conditions (eg: diabetes).
- Patients with severe or unstable upper respiratory tract infections, chronic bronchitis/asthma.
- Patients with severe inflammation and/or osteonecrosis.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry, Cairo University
Cairo
About this study
Official title: Evaluation Of Nonsurgical Treatment Of Shallow Periodontal Pockets (4-6mm) Using AIRFLOW® Prophylaxis Master Device With Erythritol Powder vs Conventional Instrumentation: A Randomized Controlled Clinical Trial
Periodontitis is a chronic condition associated with the inflammatory destruction of the periodontal tissues ultimately leading to tooth loss. Clinically, it is identified by key features such as clinical attachment loss (CAL), bleeding upon probing (BOP), and an increase in probing pocket depth (PPD), and/or gingival recession. Periodontitis is mediated by polymicrobial dysbiosis with keystone pathogens affecting the virulence of the entire biofilm community. The removal of this biofilm and its retention factors is the ultimate goal of clinical treatment and oral measures applied. The elimination of the biofilm has traditionally been achieved with the use of either hand instruments or power driven devices. Promoting periodontal health or diminishing bacterial presence and calculus buildup on teeth can be accomplished with the same efficacy whether using manual scalers and curettes or ultrasonic scaling instruments.
Both hand and ultrasonic instruments are characterized by being time-consuming and requiring technical skill, often causing patient discomfort and post-treatment pain, including hypersensitivity resulting from the loss of hard tissue when scaling the tooth surface. Ultrasonic instruments tend to leave a rougher surface behind compared to hand instruments. While effective the current techniques all have their disadvantages.
The aim of this study is to evaluate changes in probing depth clinically, Bleeding on probing, Clinical attachment level, Plaque index, Calculus index, Patient pain/discomfort, Patient satisfaction, Cost effectiveness, Treatment time and Number of pockets closed after using AIRFLOW® Prophylaxis Master device with erythritol powder.
Read the detailed description
Patients will be selected from the outpatient clinic of the Oral Medicine and Periodontology Department, Faculty of Dentistry-Cairo University
- Screening of patients will continue until the target sample is achieved. (Consecutive sampling)
- Identifying and recruiting potential subjects will be achieved through patient database.
Preoperative evaluation:
- Clinical examination
Each patient will be examined to confirm that he/she met the eligibility criteria.
Age, gender and smoking status will be collected at baseline, along with a complete periodontal charting including 6-point pocket probing depth (PPD), clinical attachment level (CAL), plaque index (PI) according to a modified O'Leary index (O'Leary et al. 1972) measured on 6 surfaces per tooth (distobuccal, buccal, mesiobuccal, distolingual, lingual and mesiolingual), Calculus index according to (Ramfjord SP. 1967).
Periapical x-rays will be taken to confirm the diagnosis of periodontitis.
- Clinical photographs Clinical photographs will be taken at baseline, immediately after treatment and 6 months after treatment.
- Radiographic examination Periapicals radiographs will be taken at the site of interest at baseline and after 3 and 6 months.
- Surgical procedure
Test sites:
- Disclosure of biofilm with erythrosine,
- Removal of supragingival and subgingival (up to 4 mm) biofilm and stains with the use of AIRFLOW® Master Piezon® with AIRFLOW® PLUS powder (EMS- Dental, Nyon Switzerland).
- Supra- and sub- gingival debridement by using the AIRFLOW® Master Piezon® device with Piezon NO PAIN® (EMS-Dental) technology.
Controls will receive conventional treatment with the combination of ultrasonic and hand instrumentation only. Pockets ≥4 mm will be subgingivally debrided using the piezo device according to manufacturer's instructions, and hand curettes will be used until the operator considers the surfaces to be sufficiently clean and free of deposits.
- Postoperative: At the end of the session, the patients will receive oral hygiene instructions on manual toothbrushing and the use of interdental cleaning devices.
- Being tested
- Electro Medical Systems AIRFLOW® Prophylaxis Master Device, Hand and ultrasonic scalers and curettes
- Keywords
- Air Abrasive, Erythritol
- Medical subject headings
- Periodontal Pocket, Periodontitis, Gingival Diseases, Gingival Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electro Medical Systems AIRFLOW® Prophylaxis Master DeviceDevice
- Disclosure of biofilm with erythrosine,
- Removal of supragingival and subgingival (up to 4 mm) biofilm and stains with the use of AIRFLOW® Master Piezon® with AIRFLOW® PLUS powder (EMS- Dental, Nyon Switzerland).
- Supra- and sub- gingival debridement by using the AIRFLOW® Master Piezon® device with Piezon NO PAIN® (EMS-Dental) technology.
Hand and ultrasonic scalers and curettesOther
Combination of ultrasonic and hand instrumentation only. Pockets ≥4 mm will be subgingivally debrided using the piezo device according to manufacturer's instructions, and hand curettes will be used until the operator considers the surfaces to be sufficiently clean and free of deposits.
| Study group | Role | What they receive |
|---|---|---|
| Hand and ultrasonic scalers and curettes | Experimental | Hand and ultrasonic scalers and curettes will be used for supra- and subgingival instrumentation. Receives: Other: Hand and ultrasonic scalers and curettes |
| Electro Medical Systems AIRFLOW® Prophylaxis Master Device With Erythritol Powder | Active comparator | An erythritol powder will be used by Electro Medical Systems AIRFLOW® Prophylaxis Master Device. Receives: Device: Electro Medical Systems AIRFLOW® Prophylaxis Master Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in probing pocket depth
The PPD will be clinically measured by using UNC 15 periodontal probe from the gingival margin to the depth of the pocket.
Measured: PPD will be taken at baseline, 1 month, 3 months and 6months after the intervention during the follow-up period and will be done by a single calibrated examiner.
Secondary outcomes (9)
Bleeding On Probing
The BoP will be clinically measured by using UNC 15 periodontal probe from the CEJ to the gingival margin.
Measured: BoP will be taken at baseline, 1 month, 3 months and 6months after the intervention during the follow-up period and will be done by a single calibrated examiner.
Clinical Attachment Level
The CAL will be clinically measured using UNC 15 periodontal probe from the cemento-enamel junction (CEJ) to the depth of defect.
Measured: CAL gain will be taken at baseline, 3 months and 6 months after the intervention during the follow-up period and will be done by a single calibrated examiner.
Plaque index
The PI will be evaluated by using modified O'Leary index teeth are stained with a disclosing solution, presence of plaque is scored on a dichotomous variable and the final score per individual is the sum of the plaque scores divided by the number of surfaces examined.
Measured: PI will be measured baseline, 1 month, 3 months and 6 months after the intervention during the follow-up period and will be done by a single calibrated examiner
Calculus index
0 =absence of calculus
- =supragingival calculus extending only slightly below the free gingival margin (not more than 1 mm.)
- = moderate amount of supra and subgingival calculus or subgingival calculus alone
- = an abundance of supra and subgingival calculus
Measured: CI will be taken at baseline, 1 month, 3 months and 6months after the intervention during the follow-up period and will be done by a single calibrated examiner.
Patient pain/discomfort
Postoperative Pain will be measured by using visual analogue score (0-10)
Measured: Postoperative Pain will be measured after the surgical procedure and 1 month, 3 months and 6 months after the intervention
Patient satisfaction
Patient satisfaction will be measured using a survey.
Measured: Patient satisfaction will be measured after the surgical procedure and 1 month, 3 months and 6 months after the intervention
Cost effectiveness
Ratio of cost of treatment and time of procedure against the gained clinical benefit
Measured: At Baseline and 6 months post-op
Treatment time
Time from picking-up the handpiece from the instrument holder to put the handpiece back.
Measured: Up to 6 months
Number of healed pockets
Pocket depth of <3.5 mm clinically measured by using UNC 15 periodontal probe from the gingival margin to the depth of the pocket.
Measured: 6 months post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start1 Mar 2024
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal PocketStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asim Tariqu Al Ammour, Cairo University
- Investigators
- Hani El-Nahas, Professor, Study director, Cairo UniversityOmnia Tawfik, Lecturer, Study chair, Cairo UniversityAsim Al Ammour, Bachelor, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06351982
- Sponsor's protocol ID
- 211123PER3-3-2
- Status last verified
- Apr 2024
- First submitted
- 20 Mar 2024
- Last updated
- 8 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of Nonsurgical Treatment Of Shallow Periodontal Pockets (4-6mm) Using AIRFLOW® Prophylaxis Master Device With Erythritol Powder vs Conventional Instrumentation: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06351982
- Acronym / sponsor ID
- 211123PER3-3-2
- Keywords
- Air Abrasive, Erythritol
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 8 Apr 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.
Periodontitis is a chronic condition associated with the inflammatory destruction of the periodontal tissues ultimately leading to tooth loss. Clinically, it is identified by key features such as clinical attachment loss (CAL), bleeding upon probing (BOP), and an increase in probing pocket depth (PPD), and/or gingival recession. Periodontitis is mediated by polymicrobial dysbiosis with keystone pathogens affecting the virulence of the entire biofilm community. The removal of this biofilm and its retention factors is the ultimate goal of clinical treatment and oral measures applied. The elimination of the biofilm has traditionally been achieved with the use of either hand instruments or power driven devices. Promoting periodontal health or diminishing bacterial presence and calculus buildup on teeth can be accomplished with the same efficacy whether using manual scalers and curettes or ultrasonic scaling instruments.
Both hand and ultrasonic instruments are characterized by being time-consuming and requiring technical skill, often causing patient discomfort and post-treatment pain, including hypersensitivity resulting from the loss of hard tissue when scaling the tooth surface. Ultrasonic instruments tend to leave a rougher surface behind compared to hand instruments. While effective the current techniques all have their disadvantages.
The aim of this study is to evaluate changes in probing depth clinically, Bleeding on probing, Clinical attachment level, Plaque index, Calculus index, Patient pain/discomfort, Patient satisfaction, Cost effectiveness, Treatment time and Number of pockets closed after using AIRFLOW® Prophylaxis Master device with erythritol powder.
Detailed description
Patients will be selected from the outpatient clinic of the Oral Medicine and Periodontology Department, Faculty of Dentistry-Cairo University
- Screening of patients will continue until the target sample is achieved. (Consecutive sampling)
- Identifying and recruiting potential subjects will be achieved through patient database.
Preoperative evaluation:
- Clinical examination
Each patient will be examined to confirm that he/she met the eligibility criteria.
Age, gender and smoking status will be collected at baseline, along with a complete periodontal charting including 6-point pocket probing depth (PPD), clinical attachment level (CAL), plaque index (PI) according to a modified O'Leary index (O'Leary et al. 1972) measured on 6 surfaces per tooth (distobuccal, buccal, mesiobuccal, distolingual, lingual and mesiolingual), Calculus index according to (Ramfjord SP. 1967).
Periapical x-rays will be taken to confirm the diagnosis of periodontitis.
- Clinical photographs Clinical photographs will be taken at baseline, immediately after treatment and 6 months after treatment.
- Radiographic examination Periapicals radiographs will be taken at the site of interest at baseline and after 3 and 6 months.
- Surgical procedure
Test sites:
- Disclosure of biofilm with erythrosine,
- Removal of supragingival and subgingival (up to 4 mm) biofilm and stains with the use of AIRFLOW® Master Piezon® with AIRFLOW® PLUS powder (EMS- Dental, Nyon Switzerland).
- Supra- and sub- gingival debridement by using the AIRFLOW® Master Piezon® device with Piezon NO PAIN® (EMS-Dental) technology.
Controls will receive conventional treatment with the combination of ultrasonic and hand instrumentation only. Pockets ≥4 mm will be subgingivally debrided using the piezo device according to manufacturer's instructions, and hand curettes will be used until the operator considers the surfaces to be sufficiently clean and free of deposits.
- Postoperative: At the end of the session, the patients will receive oral hygiene instructions on manual toothbrushing and the use of interdental cleaning devices.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hand and ultrasonic scalers and curettes | Experimental | Other: Hand and ultrasonic scalers and curettesHand and ultrasonic scalers and curettes will be used for supra- and subgingival instrumentation. |
| Electro Medical Systems AIRFLOW® Prophylaxis Master Device With Erythritol Powder | Active comparator | Device: Electro Medical Systems AIRFLOW® Prophylaxis Master DeviceAn erythritol powder will be used by Electro Medical Systems AIRFLOW® Prophylaxis Master Device. |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Systemically healthy patients.
- Patients with an age range between 16 to 80 years.
- Patients have a minimum of 20 teeth.
- Periodontitis patients with at least one residual pocket with a probing depth ranging from 4 to 6 mm.
- Cooperative patients able and willing to come for follow up appointments.
Key exclusion criteria (4 listed)
- Pregnant and lactation females.
- Patients reporting systemic conditions (eg: diabetes).
- Patients with severe or unstable upper respiratory tract infections, chronic bronchitis/asthma.
- Patients with severe inflammation and/or osteonecrosis.
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 |
|---|---|---|
| Electro Medical Systems AIRFLOW® Prophylaxis Master Device1. Disclosure of biofilm with erythrosine, 2. Removal of supragingival and subgingival (up to 4 mm) biofilm and stains with the use of AIRFLOW® Master Piezon® with AIRFLOW® PLUS powder (EMS- Dental, Nyon Switzerland). 3. Supra- and sub- gingival debridement by using the AIRFLOW® Master Piezon® device with Piezon NO PAIN® (EMS-Dental) technology. | Device | Electro Medical Systems AIRFLOW® Prophylaxis Master Device With Erythritol Powder |
| Hand and ultrasonic scalers and curettesCombination of ultrasonic and hand instrumentation only. Pockets ≥4 mm will be subgingivally debrided using the piezo device according to manufacturer's instructions, and hand curettes will be used until the operator considers the surfaces to be sufficiently clean and free of deposits. | Other | Hand and ultrasonic scalers and curettes |
Primary outcome
Change in probing pocket depth
Time frame: PPD will be taken at baseline, 1 month, 3 months and 6months after the intervention during the follow-up period and will be done by a single calibrated examiner.
The PPD will be clinically measured by using UNC 15 periodontal probe from the gingival margin to the depth of the pocket.
9 secondary outcomes
Bleeding On Probing
Time frame: BoP will be taken at baseline, 1 month, 3 months and 6months after the intervention during the follow-up period and will be done by a single calibrated examiner.
Clinical Attachment Level
Time frame: CAL gain will be taken at baseline, 3 months and 6 months after the intervention during the follow-up period and will be done by a single calibrated examiner.
Plaque index
Time frame: PI will be measured baseline, 1 month, 3 months and 6 months after the intervention during the follow-up period and will be done by a single calibrated examiner
Calculus index
Time frame: CI will be taken at baseline, 1 month, 3 months and 6months after the intervention during the follow-up period and will be done by a single calibrated examiner.
Patient pain/discomfort
Time frame: Postoperative Pain will be measured after the surgical procedure and 1 month, 3 months and 6 months after the intervention
Patient satisfaction
Time frame: Patient satisfaction will be measured after the surgical procedure and 1 month, 3 months and 6 months after the intervention
Cost effectiveness
Time frame: At Baseline and 6 months post-op
Treatment time
Time frame: Up to 6 months
Number of healed pockets
Time frame: 6 months post-op
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2024.
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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.
Hani El-Nahas, Professor study director
Cairo University
Omnia Tawfik, Lecturer study chair
Cairo University
Asim Al Ammour, Bachelor principal investigator
Cairo 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 Electro Medical Systems AIRFLOW® Prophylaxis Master Device and Hand and ultrasonic scalers and curettes in people with Periodontal Pocket and Periodontitis, run by Cairo University 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 5 inclusion and 4 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 8 Apr 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Asim Al Ammour, Bachelor (+201030593878, asim.alammour@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in probing pocket depth (time frame: PPD will be taken at baseline, 1 month, 3 months and 6months after the intervention during the follow-up period and will be done by a single calibrated examiner.). 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 8 Apr 2024.