Pocket, PeriodontalPhase 1NCT06404190
Diode Laser Photo Activation for Pocket Reduction Decontamination A Clinical Study
A Phase 1 study testing Diode laser and 3% hydrogen peroxide in people with Pocket, Periodontal and Periodontal Inflammation, run by Krishnadevaraya College of Dental Sciences & Hospital at 1 site in India.
Trial summary
Routine non surgical periodontal thearpy often fails to achieve complete elimination of pathogenic microorganism. This could be attiributable to deep periodontal pockets, root concavities, furcation involvement etc. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Pocket, Periodontal, Periodontal Inflammation, Periodontal Attachment Loss
- What is being tested?
- Diode laser and 3% hydrogen peroxide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIndia
- Study dates
- 28 May 2023to 15 Sep 2023
- Phase
- Phase 1
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients ≥18 years of age Minimum of 5mm of periodontal probing depth Patient under going orthodontic prosthodontic restorative treatment Stage 2 and 3 Grade B and C periodontitis acc to 2017 classification
- Exclusive Criteria:
- Pregnacy systemic disease people
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: DIODE LASER PHOTOACTIVATION OF 3% HYDROGEN PEROXIDE FOR POCKET DECONTAMINATION A CLINICAL STUDY
Routine non surgical periodontal thearpy often fails to achieve complete elimination of pathogenic microorganism. This could be attiributable to deep periodontal pockets, root concavities, furcation involvement etc. Systemic and local antimicrobials have been used adjunctively with scaling and root planning to optimize the results. They have their own draw backs namely antibiotic resistance and narrow spectrum of action over periodontal pathogens. In the last decade lasers applications have diversified occupying greater part of the periodontal treatment strategies. Photodynamic thearpy has shown conflicting results as a adjunctive thearpy. The routinely used dyes are Methyelene blue, indocyanine green and rose bengal .These dyes are difficult to procure and may not be economical . Hydrogen peroxide due to its super radicals has a local antimicrobial effect. Since hydrogen peroxide can be easily available in a clinical setting and is cost effective. It could be used for photodisinfection . From the near-infrared spectrum lasers, the Nd-YAG laser can remove periodontal pathogens because of its thermal effect. However, changes in the neighboring tissues can be attributed to these unwanted thermal effects. The diode lasers that belong to the 655-980 nm spectrum could represent a safer alternative.Because of the transmission or scattering effect on hydroxyapatite, diode lasers have no effect on calculus. Anaerobic bacterial species intermedia produce black pigments in Brucella media from blood agar. Hemoglobin in the soft periodontal tissues behaves like a chromophore, being absorbed by the diode laser. Photoactivated procedure use photolysis of hydrogen peroxide with 810nm laser. It acts as an endogenous dye, which can increase the laser effect at this level and also generate ROS stopped immediately after the laser irridation. Therefore, the diode laser stimulation of 3%hydrogen peroxide has been utilized adjuvantive to SRP to optimize clinical outcome.
Read the detailed description
This study was designed as a randomized controlled single-blind clinical trial to assest the antimicrobial effect of non surgical periodontal thearpy with SRP alone , and photoactivation of 3% H2O2 with 810nm diode in combination with SRP. Based on the method of randomization, each patient was allocated to one of the two treatment groups as follows: Group 1: SRP as monotherapy; Group 2: SRP+H2O2photoactivation with diode laser. One week after the baseline periodontal examination and microbiological sampling, scaling and root planning is carried out using conventional ultrasonic scaler .Every patient received oral hygiene instructions that included modified BASS brushing technique . In Group 1- Only SRP: Group 2- 3% H2O2solution was inserted to the bottom of the periodontal pocket using a disposable plastic needle similar to the endodontic irrigation followed by diode 810 nm laser irridation with 1.1 W, continuous wave (CW) with 300mm The activated fiber was applied from the bottom to the free gingival margin of the periodontal pocket in parallel with the root surface and side-to-side movements were performed for*30 sec per test surface. Microbiological assessment was performed 1 week before periodontal treatment.
Microbiological samples were obtained from the selected periodontal pockets at baseline (before treatment) and at 1 month after the periodontal treatment by the examiner. Sterile paper points will be placed into periodontal pocket to collect the gcf sample for 30 sec, then it is transfer to Eppendorf tubes(individual sampling) having (thioglycate broth) and incubated for 2 hrs then broth is( vortex). Later sample is cultured on the anerobic blood agar media and incubated in gas jar with anerobic gas pack for 48hrs and colony counting is done after 48hrs of incubation. Clinical periodontal parameters PPD, BOP, CAL and mobility were assessed baseine and 3 months after the periodontal treatment.
- Being tested
- Diode laser and 3% hydrogen peroxide
- Medical subject headings
- Periodontal Pocket, Periodontal Attachment Loss, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diode laser and 3% hydrogen peroxideCombination product
Hydrogen peroxide due to its super radicals has a local antimicrobial effect. Since hydrogen peroxide can be easily available in a clinical setting and is cost-effective. It could be used for photo disinfection along with lasers.
The diode lasers that belong to the 655-980 nm spectrum could represent a safer alternative. Because of the transmission or scattering effect on hydroxyapatite, diode lasers have no effect on hard tissues and deposits. The photoactivation procedure uses photolysis of hydrogen peroxide with 810nm laser.
Hydrogen peroxide acts as an endogenous dye, which can increase the laser effect at this level and also generate ROS. Thus the combination of 3% H2O2 and laser light generate hydroxyl radicals as a result of photoactivation.
Therefore, the diode laser stimulation of 3%hydrogen peroxide has been utilized adjunctive to SRP to optimize clinical outcomes.
| Study group | Role | What they receive |
|---|---|---|
| DIODE LASER PHOTOACTIVATION OF 3% HYDROGEN-PEROXIDE FOR POCKET DECONTAMINATION - A CLINICAL STUDY | Experimental | 1)To evaluate the effectiveness of 3% hydrogen peroxide as an adjunct to scaling and root planning with diode laser irriadation 2. To compare the clinical and microbiology outcome of SRP + 3% hydrogen peroxide + diode laser and SRP alone Receives: Combination Product: Diode laser and 3% hydrogen peroxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing pocket Depth
- Probing pocket Depth (PPD), dept measuring from cej to depth of pocket through william probe
Measured: 3 months
Secondary outcomes (1)
DIODE LASER PHOTOACTIVATION OF 3% HYDROGEN-PEROXIDE FOR POCKET DECONTAMINATION - A CLINICAL STUDY
Colony count
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start28 May 2023
- Primary completion1 Aug 2023
- Study completion15 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pocket, PeriodontalStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- GROUP A: ultrasonic GROUP B: laser and hydrogen peroxide
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Krishnadevaraya College of Dental Sciences & Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06404190
- Sponsor's protocol ID
- KCDSHEC/IP/2023/P11
- Status last verified
- May 2024
- First submitted
- 10 Apr 2024
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DIODE LASER PHOTOACTIVATION OF 3% HYDROGEN PEROXIDE FOR POCKET DECONTAMINATION A CLINICAL STUDY
- ClinicalTrials.gov ID
- NCT06404190
- Acronym / sponsor ID
- KCDSHEC/IP/2023/P11
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Krishnadevaraya College of Dental Sciences & HospitalUniversity, hospital or other
- Study start
- 28 May 2023 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 8 May 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.
Routine non surgical periodontal thearpy often fails to achieve complete elimination of pathogenic microorganism. This could be attiributable to deep periodontal pockets, root concavities, furcation involvement etc. Systemic and local antimicrobials have been used adjunctively with scaling and root planning to optimize the results. They have their own draw backs namely antibiotic resistance and narrow spectrum of action over periodontal pathogens. In the last decade lasers applications have diversified occupying greater part of the periodontal treatment strategies. Photodynamic thearpy has shown conflicting results as a adjunctive thearpy. The routinely used dyes are Methyelene blue, indocyanine green and rose bengal .These dyes are difficult to procure and may not be economical . Hydrogen peroxide due to its super radicals has a local antimicrobial effect. Since hydrogen peroxide can be easily available in a clinical setting and is cost effective. It could be used for photodisinfection . From the near-infrared spectrum lasers, the Nd-YAG laser can remove periodontal pathogens because of its thermal effect. However, changes in the neighboring tissues can be attributed to these unwanted thermal effects. The diode lasers that belong to the 655-980 nm spectrum could represent a safer alternative.Because of the transmission or scattering effect on hydroxyapatite, diode lasers have no effect on calculus. Anaerobic bacterial species intermedia produce black pigments in Brucella media from blood agar. Hemoglobin in the soft periodontal tissues behaves like a chromophore, being absorbed by the diode laser. Photoactivated procedure use photolysis of hydrogen peroxide with 810nm laser. It acts as an endogenous dye, which can increase the laser effect at this level and also generate ROS stopped immediately after the laser irridation. Therefore, the diode laser stimulation of 3%hydrogen peroxide has been utilized adjuvantive to SRP to optimize clinical outcome.
Detailed description
This study was designed as a randomized controlled single-blind clinical trial to assest the antimicrobial effect of non surgical periodontal thearpy with SRP alone , and photoactivation of 3% H2O2 with 810nm diode in combination with SRP. Based on the method of randomization, each patient was allocated to one of the two treatment groups as follows: Group 1: SRP as monotherapy; Group 2: SRP+H2O2photoactivation with diode laser. One week after the baseline periodontal examination and microbiological sampling, scaling and root planning is carried out using conventional ultrasonic scaler .Every patient received oral hygiene instructions that included modified BASS brushing technique . In Group 1- Only SRP: Group 2- 3% H2O2solution was inserted to the bottom of the periodontal pocket using a disposable plastic needle similar to the endodontic irrigation followed by diode 810 nm laser irridation with 1.1 W, continuous wave (CW) with 300mm The activated fiber was applied from the bottom to the free gingival margin of the periodontal pocket in parallel with the root surface and side-to-side movements were performed for*30 sec per test surface. Microbiological assessment was performed 1 week before periodontal treatment.
Microbiological samples were obtained from the selected periodontal pockets at baseline (before treatment) and at 1 month after the periodontal treatment by the examiner. Sterile paper points will be placed into periodontal pocket to collect the gcf sample for 30 sec, then it is transfer to Eppendorf tubes(individual sampling) having (thioglycate broth) and incubated for 2 hrs then broth is( vortex). Later sample is cultured on the anerobic blood agar media and incubated in gas jar with anerobic gas pack for 48hrs and colony counting is done after 48hrs of incubation. Clinical periodontal parameters PPD, BOP, CAL and mobility were assessed baseine and 3 months after the periodontal treatment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- GROUP A: ultrasonic GROUP B: laser and hydrogen peroxide
| Arm | Type | Receives |
|---|---|---|
| DIODE LASER PHOTOACTIVATION OF 3% HYDROGEN-PEROXIDE FOR POCKET DECONTAMINATION - A CLINICAL STUDY | Experimental | Combination Product: Diode laser and 3% hydrogen peroxide1)To evaluate the effectiveness of 3% hydrogen peroxide as an adjunct to scaling and root planning with diode laser irriadation 2. To compare the clinical and microbiology outcome of SRP + 3% hydrogen peroxide + diode laser and SRP alone |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients ≥18 years of age Minimum of 5mm of periodontal probing depth Patient under going orthodontic prosthodontic restorative treatment Stage 2 and 3 Grade B and C periodontitis acc to 2017 classification
- Pregnacy systemic disease people
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Diode laser and 3% hydrogen peroxideHydrogen peroxide due to its super radicals has a local antimicrobial effect. Since hydrogen peroxide can be easily available in a clinical setting and is cost-effective. It could be used for photo disinfection along with lasers. The diode lasers that belong to the 655-980 nm spectrum could represent a safer alternative. Because of the transmission or scattering effect on hydroxyapatite, diode lasers have no effect on hard tissues and deposits. The photoactivation procedure uses photolysis of hydrogen peroxide with 810nm laser. Hydrogen peroxide acts as an endogenous dye, which can increase the laser effect at this level and also generate ROS. Thus the combination of 3% H2O2 and laser light generate hydroxyl radicals as a result of photoactivation. Therefore, the diode laser stimulation of 3%hydrogen peroxide has been utilized adjunctive to SRP to optimize clinical outcomes. | Combination product | DIODE LASER PHOTOACTIVATION OF 3% HYDROGEN-PEROXIDE FOR POCKET DECONTAMINATION - A CLINICAL STUDY |
Primary outcome
Probing pocket Depth
Time frame: 3 months
1. Probing pocket Depth (PPD), dept measuring from cej to depth of pocket through william probe
1 secondary outcome
DIODE LASER PHOTOACTIVATION OF 3% HYDROGEN-PEROXIDE FOR POCKET DECONTAMINATION - A CLINICAL STUDY
Time frame: 3 month
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 8 May 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Diode laser and 3% hydrogen peroxide in people with Pocket, Periodontal and Periodontal Inflammation, run by Krishnadevaraya College of Dental Sciences & Hospital at 1 site in India.
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 0 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 8 May 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 India. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 pocket Depth (time frame: 3 months). 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 May 2024.