PeriodontitisNCT06209554
The Efficacy of Diode Laser and Subgingival Air Polishing With Erythritol in Treatment of Periodontitis
A study testing ultrasonic tips and Gracey curettes, airflow with erythritol and diode laser in people with Periodontitis, run by sara mohamed awad elmeligy at 1 site in Egypt.
Trial summary
The present study aims to evaluate the efficacy of subgingival air polishing by erythritol and diode laser in the treatment of periodontitis (clinically and microbiologically). Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Periodontitis
- What is being tested?
- ultrasonic tips and Gracey curettes, airflow with erythritol and diode laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 13 Jan 2023to 17 Mar 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Systemically healthy patients. Patient with stageІ\& stage ІІ periodontitis according to Classification of periodontal and peri-implant diseases and conditions 2017
Who cannot join
- Patients with any systemic disease linked to delayed wound healing, such as uncontrolled diabetes, autoimmune diseases, heart conditions, etc.
- Current smokers. Patients underwent prior periodontal therapy within the last 6 months. Individuals who had used antibiotics in the previous 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Diode Laser and Subgingival Air Polishing With Erythritol in Treatment of Periodontitis ( Clinical and Microbiological Study)
The present study aims to evaluate the efficacy of subgingival air polishing by erythritol and diode laser in the treatment of periodontitis (clinically and microbiologically).
Read the detailed description
Periodontitis, a chronic condition, leads to inflammation of the periodontium, resulting in the degradation of the periodontal ligament and adjacent alveolar bone, potentially leading to tooth loss The oral cavity, hosting nearly 700 distinct bacteria, is the primary origin of periodontitis, where bacterial pathogens trigger an inflammatory response, causing connective tissue deterioration. Gram-negative bacteria, including Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Prevotella intermedia, and Tannerella forsythia, contribute to periodontitis.
Dental plaque illustrates bacterial growth in the form of a biofilm Porphyromonas gingivalis, a Gram-negative anaerobic bacterium, is found in 85.75% of subgingival plaques associated with chronic periodontitis. The presence of Aggregatibacter actinomycetemcomitans at the individual level is notably associated with disease risk due to its genetic variation and virulence factors.
Exclusive reliance on mechanical therapy (SRP) may fall short in eliminating pathogenic bacterial species due to their presence within periodontal tissues or in regions inaccessible by periodontal instruments during close debridement. These challenges pose constraints on the enduring stability of outcomes in nonsurgical techniques, forming the rationale for supplementary therapies involving antibiotics, antiseptics, nonchemical modalities, laser, and photodynamic therapy.
Laser therapy, particularly the diode laser at 940 nm, in conjunction with SRP, enhances and facilitates the healing process in treated sites. The diode laser, preferred for its cost-effectiveness, portability, and user-friendly nature, simultaneously addresses the removal of diseased soft tissues, targets microorganisms, and induces an antibacterial effect within periodontal pockets.
Its favorable tissue penetration capabilities and absorption in pigmented tissues make it particularly adept at targeting pigmented bacteria and granulation tissue.
The emergence of low-abrasive and resorbable powders, used with subgingival delivery tools, sparks renewed interest in air-polishing devices (APDs) for periodontal treatment. Research indicates that APDs contribute to a reduction in post-operative patient discomfort and sensitivity, enhance patient acceptance, and result in minimal alterations to surrounding soft and hard tissues. Air-flow therapy may be particularly beneficial for challenging cases such as teeth with furcation involvement and sites with restricted access, traditionally posing difficulties for thorough debridement using conventional instrumentation.
Initially designed to eliminate biofilm and stains, APDs using abrasive powders were found detrimental to exposed root surfaces, gingiva, and certain restorative materials. Subsequently, there was a shift towards the adoption of resorbable powders with low abrasiveness, including glycine and erythritol, to mitigate adverse effects.
The recently introduced erythritol powder, a water-soluble, non-toxic sugar alcohol, and artificial sweetener, is extensively employed in the food industry. Erythritol powder air-polishing (EPAP) used as a monotherapy exhibits outcomes in supportive periodontal therapy comparable to those achieved through conventional power-driven and manual debridement.
There is a suggestion that erythritol powder may possess a prolonged antimicrobial effect on the subgingival biofilm, with studies indicating its capability to decrease the numbers of P. gingivalis and Aggregatibacter actinomycetemcomitans during supportive periodontal treatment.
- Conditions
- Periodontitis
- Being tested
- ultrasonic tips and Gracey curettes, airflow with erythritol and diode laser
- Keywords
- Diode laser, Erythritol
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasonic tips and Gracey curettes, airflow with erythritol and diode laserDevice
diode laser and erythritol used as adjunctive method in the treatment of periodontitis in addition to scaling and root planning
| Study group | Role | What they receive |
|---|---|---|
| control group | Experimental | Eight patients to be treated with only Scaling and root planning . Receives: Device: ultrasonic tips and Gracey curettes, airflow with erythritol and diode laser |
| erythritol group | Experimental | Eight patients to be treated with erythritol air polishing as an adjunct to Scaling and root planning . Receives: Device: ultrasonic tips and Gracey curettes, airflow with erythritol and diode laser |
| laser group | Experimental | Eight patients to be treated with dioad laser as an adjunct to Scaling and root planning . Receives: Device: ultrasonic tips and Gracey curettes, airflow with erythritol and diode laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
probing depth and clinical attachment loss
decreasing probing depth and clinical attachment loss refer to healing of periodontal pocket
Measured: baseline and 6 weeks follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start13 Jan 2023
- Primary completion1 Mar 2023
- Study completion17 Mar 2023
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 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, Care provider
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- sara mohamed awad elmeligy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, sara mohamed awad elmeligy, Mansoura University
- Investigators
- samah H elmeadawy, ph.D, Study chair, Mansoura U
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06209554
- Sponsor's protocol ID
- treatment of periodontitis
- Status last verified
- Jan 2024
- First submitted
- 8 Jan 2024
- Last updated
- 23 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: it is difficult to be in direct contact with patient after work is finished ,due to the distance.
Publications
Elmeligy SMA, Saleh W, Elewa GM, Abu El-Ezz HZ, Mahmoud NM, Elmeadawy S. The efficacy of diode laser and subgingival air polishing with erythritol in treatment of periodontitis (clinical and microbiological study). BMC Oral Health. 2024 Jul 4;24(1):763. doi: 10.1186/s12903-024-04481-6.
PubMed 38965550
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Diode Laser and Subgingival Air Polishing With Erythritol in Treatment of Periodontitis ( Clinical and Microbiological Study)
- ClinicalTrials.gov ID
- NCT06209554
- Acronym / sponsor ID
- treatment of periodontitis
- Conditions
- Periodontitis
- Keywords
- Diode laser, Erythritol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- sara mohamed awad elmeligyUniversity, hospital or other
- Study start
- 13 Jan 2023 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 17 Mar 2023 (actual)
- First posted
- 17 Jan 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 present study aims to evaluate the efficacy of subgingival air polishing by erythritol and diode laser in the treatment of periodontitis (clinically and microbiologically).
Detailed description
Periodontitis, a chronic condition, leads to inflammation of the periodontium, resulting in the degradation of the periodontal ligament and adjacent alveolar bone, potentially leading to tooth loss The oral cavity, hosting nearly 700 distinct bacteria, is the primary origin of periodontitis, where bacterial pathogens trigger an inflammatory response, causing connective tissue deterioration. Gram-negative bacteria, including Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Prevotella intermedia, and Tannerella forsythia, contribute to periodontitis.
Dental plaque illustrates bacterial growth in the form of a biofilm Porphyromonas gingivalis, a Gram-negative anaerobic bacterium, is found in 85.75% of subgingival plaques associated with chronic periodontitis. The presence of Aggregatibacter actinomycetemcomitans at the individual level is notably associated with disease risk due to its genetic variation and virulence factors.
Exclusive reliance on mechanical therapy (SRP) may fall short in eliminating pathogenic bacterial species due to their presence within periodontal tissues or in regions inaccessible by periodontal instruments during close debridement. These challenges pose constraints on the enduring stability of outcomes in nonsurgical techniques, forming the rationale for supplementary therapies involving antibiotics, antiseptics, nonchemical modalities, laser, and photodynamic therapy.
Laser therapy, particularly the diode laser at 940 nm, in conjunction with SRP, enhances and facilitates the healing process in treated sites. The diode laser, preferred for its cost-effectiveness, portability, and user-friendly nature, simultaneously addresses the removal of diseased soft tissues, targets microorganisms, and induces an antibacterial effect within periodontal pockets.
Its favorable tissue penetration capabilities and absorption in pigmented tissues make it particularly adept at targeting pigmented bacteria and granulation tissue.
The emergence of low-abrasive and resorbable powders, used with subgingival delivery tools, sparks renewed interest in air-polishing devices (APDs) for periodontal treatment. Research indicates that APDs contribute to a reduction in post-operative patient discomfort and sensitivity, enhance patient acceptance, and result in minimal alterations to surrounding soft and hard tissues. Air-flow therapy may be particularly beneficial for challenging cases such as teeth with furcation involvement and sites with restricted access, traditionally posing difficulties for thorough debridement using conventional instrumentation.
Initially designed to eliminate biofilm and stains, APDs using abrasive powders were found detrimental to exposed root surfaces, gingiva, and certain restorative materials. Subsequently, there was a shift towards the adoption of resorbable powders with low abrasiveness, including glycine and erythritol, to mitigate adverse effects.
The recently introduced erythritol powder, a water-soluble, non-toxic sugar alcohol, and artificial sweetener, is extensively employed in the food industry. Erythritol powder air-polishing (EPAP) used as a monotherapy exhibits outcomes in supportive periodontal therapy comparable to those achieved through conventional power-driven and manual debridement.
There is a suggestion that erythritol powder may possess a prolonged antimicrobial effect on the subgingival biofilm, with studies indicating its capability to decrease the numbers of P. gingivalis and Aggregatibacter actinomycetemcomitans during supportive periodontal treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control group | Experimental | Device: ultrasonic tips and Gracey curettes, airflow with erythritol and diode laserEight patients to be treated with only Scaling and root planning . |
| erythritol group | Experimental | Device: ultrasonic tips and Gracey curettes, airflow with erythritol and diode laserEight patients to be treated with erythritol air polishing as an adjunct to Scaling and root planning . |
| laser group | Experimental | Device: ultrasonic tips and Gracey curettes, airflow with erythritol and diode laserEight patients to be treated with dioad laser as an adjunct to Scaling and root planning . |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Systemically healthy patients. Patient with stageІ\& stage ІІ periodontitis according to Classification of periodontal and peri-implant diseases and conditions 2017
Key exclusion criteria (2 listed)
- Patients with any systemic disease linked to delayed wound healing, such as uncontrolled diabetes, autoimmune diseases, heart conditions, etc.
- Current smokers. Patients underwent prior periodontal therapy within the last 6 months. Individuals who had used antibiotics in the previous 6 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 |
|---|---|---|
| ultrasonic tips and Gracey curettes, airflow with erythritol and diode laserdiode laser and erythritol used as adjunctive method in the treatment of periodontitis in addition to scaling and root planning | Device | control group, erythritol group, laser group |
Primary outcome
probing depth and clinical attachment loss
Time frame: baseline and 6 weeks follow up
decreasing probing depth and clinical attachment loss refer to healing of periodontal pocket
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
- Derived from this study: PubMed 38965550Elmeligy SMA, Saleh W, Elewa GM, Abu El-Ezz HZ, Mahmoud NM, Elmeadawy S. The efficacy of diode laser and subgingival air polishing with erythritol in treatment of periodontitis (clinical and microbiological study). BMC Oral Health. 2024 Jul 4;24(1):763. doi: 10.1186/s12903-024-04481-6.
- Individual participant dataSharing planned: No. it is difficult to be in direct contact with patient after work is finished ,due to the distance.
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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.
samah H elmeadawy, ph.D study chair
Mansoura U
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 tips and Gracey curettes, airflow with erythritol and diode laser in people with Periodontitis, run by sara mohamed awad elmeligy 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 1 inclusion and 2 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: finished, as of the sponsor's last update on 23 Jan 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
probing depth and clinical attachment loss (time frame: baseline and 6 weeks follow up). 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 NCT06209554, 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 23 Jan 2024.