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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Egypt1 site
  • Mansoura Univeristy

    Al Mansurah

Other trials in Egypt

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 groups in NCT06209554
Study groupRoleWhat they receive
control groupExperimentalEight patients to be treated with only Scaling and root planning .
Receives: Device: ultrasonic tips and Gracey curettes, airflow with erythritol and diode laser
erythritol groupExperimentalEight 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 groupExperimentalEight 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.

  1. 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.

  1. First posted17 Jan 2024
  2. Study start13 Jan 2023
  3. Primary completion1 Mar 2023
  4. Study completion17 Mar 2023

Resources

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)
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

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.

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