Chronic PeriodontitisNCT03028727
Diode Laser Therapy As An Adjunct To Scaling And Root Planing
A study testing Ultrasonic Scaling and root planing and 980 nm diode laser irradiation in people with Chronic Periodontitis, run by KLE Society's Institute of Dental Sciences.
Trial summary
Laser therapy has been proposed as a novel treatment option in controlling subgingival microorganisms. This randomized controlled clinical trial evaluates the effect of 980nm diode laser as an adjunct to scaling and root planing (SRP) in the management of chronic periodontitis (CP). Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Chronic Periodontitis
- What is being tested?
- Ultrasonic Scaling and root planing and 980 nm diode laser irradiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Mar 2013to Sep 2013
- 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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 40 systemically healthy subjects diagnosed with generalized moderate CP in the age group of 30 to 50 years.
- Minimum of 20 teeth having atleast two non-adjacent sites per quadrant with probing pocket depth of ≥ 5mm and clinical attachment loss of 3- 4 mm
Who cannot join
- Patients who had undergone periodontal therapy 6 months prior to the commencement of the study.
- Subjects on antibiotics or immunosuppressants.
- Chronic smokers, alcoholics, smokeless tobacco users.
- Subjects with acute illnesses/acute intraoral lesions.
- Pregnant women
- Subjects who had undergone extensive restorative dental treatment.
About this study
Official title: Diode Laser Therapy As An Adjunct To Non-Surgical Management Of Chronic Periodontitis - A Pilot Study
Laser therapy has been proposed as a novel treatment option in controlling subgingival microorganisms. This randomized controlled clinical trial evaluates the effect of 980nm diode laser as an adjunct to scaling and root planing (SRP) in the management of chronic periodontitis (CP).
Read the detailed description
Conventional mechanical debridement can achieve a temporary decrease in the subgingival levels of Pg along with other pathogens. However, mechanical therapy alone may fail to eliminate pathogenic bacterial niches in inaccessible areas like deep pockets, root concavities, furcation areas etc. In search of more efficient and less traumatic techniques to improve periodontal healing, researchers proposed the use of lasers in periodontal therapy.
The adjunctive use of lasers with conventional tools may facilitate treatment and have the potential to improve healing. The diode laser is highly absorbed in hemoglobin and other pigments and is excellent for use in soft tissue surgical procedures.Laser application in improving clinical outcome in periodontal therapy, needs to be further investigated with well designed clinical trials. The investigators attempted to evaluate the efficacy of diode laser as an adjunct to SRP in the management of CP by evaluating clinical parameters coupled with quantitative estimation of P.gingivalis using Real-time Polymerase chain reaction (RT-PCR) assay.
- Conditions
- Chronic Periodontitis
- Being tested
- Ultrasonic Scaling and root planing, 980 nm diode laser irradiation
- Medical subject headings
- Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonic Scaling and root planingProcedure or surgery
Procedure of scaling and root planing at day 0 and at 1 week
980 nm diode laser irradiationProcedure or surgery
Procedure of scaling and root planing and application of 980 nm diode laser at day 0 and at 1 week
| Study group | Role | What they receive |
|---|---|---|
| Ultrasonic Scaling, Root planing | Active comparator | Ultrasonic Scaling and Root planing at day 0 and at 1 week. Receives: Procedure: Ultrasonic Scaling and root planing |
| 980 nm diode Laser irradiation | Experimental | Irradiation of periodontal pockets with with 980 nm diode Laser after scaling and root planing at day 0 and after 1 week. Receives: Procedure: Ultrasonic Scaling and root planing; Procedure: 980 nm diode laser irradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in levels of P.gingivalis
Microbial profile was assessed using PCR at baseline, 4-6 weeks and 12-14 weeks post treatment in both the study groups.
Measured: 14 weeks
Secondary outcomes (4)
Change in gingival index
Gingival index by Loe and Silness was assessed at baseline, 4-6 weeks and 12-14 weeks post treatment in both the groups
Measured: 14 weeks
Change in plaque index
Plaque index by Silness and Loe was assessed at baseline, 4-6 weeks and 12-14 weeks
Measured: 14 weeks
Change in probing pocket depth
Probing pocket depth was assessed at baseline, 4-6 weeks and 12-14 weeks
Measured: 14 weeks
Change in clinical attachment level
Clinical attachment level was assessed at baseline, 4-6 weeks and 12-14 weeks
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2017 (estimated)
- Study startMar 2013
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- KLE Society's Institute of Dental Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Veena H.R, KLE Society's Institute of Dental Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03028727
- Sponsor's protocol ID
- KLESocietyIDS
- Status last verified
- Jan 2017
- First submitted
- 7 Jan 2017
- Last updated
- 23 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diode Laser Therapy As An Adjunct To Non-Surgical Management Of Chronic Periodontitis - A Pilot Study
- ClinicalTrials.gov ID
- NCT03028727
- Acronym / sponsor ID
- KLESocietyIDS
- Conditions
- Chronic Periodontitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- KLE Society's Institute of Dental SciencesUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 23 Jan 2017 (estimated)
- 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.
Laser therapy has been proposed as a novel treatment option in controlling subgingival microorganisms. This randomized controlled clinical trial evaluates the effect of 980nm diode laser as an adjunct to scaling and root planing (SRP) in the management of chronic periodontitis (CP).
Detailed description
Conventional mechanical debridement can achieve a temporary decrease in the subgingival levels of Pg along with other pathogens. However, mechanical therapy alone may fail to eliminate pathogenic bacterial niches in inaccessible areas like deep pockets, root concavities, furcation areas etc. In search of more efficient and less traumatic techniques to improve periodontal healing, researchers proposed the use of lasers in periodontal therapy.
The adjunctive use of lasers with conventional tools may facilitate treatment and have the potential to improve healing. The diode laser is highly absorbed in hemoglobin and other pigments and is excellent for use in soft tissue surgical procedures.Laser application in improving clinical outcome in periodontal therapy, needs to be further investigated with well designed clinical trials. The investigators attempted to evaluate the efficacy of diode laser as an adjunct to SRP in the management of CP by evaluating clinical parameters coupled with quantitative estimation of P.gingivalis using Real-time Polymerase chain reaction (RT-PCR) assay.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasonic Scaling, Root planing | Active comparator | Procedure: Ultrasonic Scaling and root planingUltrasonic Scaling and Root planing at day 0 and at 1 week. |
| 980 nm diode Laser irradiation | Experimental | Procedure: Ultrasonic Scaling and root planing, Procedure: 980 nm diode laser irradiationIrradiation of periodontal pockets with with 980 nm diode Laser after scaling and root planing at day 0 and after 1 week. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 40 systemically healthy subjects diagnosed with generalized moderate CP in the age group of 30 to 50 years.
- Minimum of 20 teeth having atleast two non-adjacent sites per quadrant with probing pocket depth of ≥ 5mm and clinical attachment loss of 3- 4 mm
Key exclusion criteria (6 listed)
- Patients who had undergone periodontal therapy 6 months prior to the commencement of the study.
- Subjects on antibiotics or immunosuppressants.
- Chronic smokers, alcoholics, smokeless tobacco users.
- Subjects with acute illnesses/acute intraoral lesions.
- Pregnant women
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 Scaling and root planingProcedure of scaling and root planing at day 0 and at 1 week | Procedure or surgery | 980 nm diode Laser irradiation, Ultrasonic Scaling, Root planing |
| 980 nm diode laser irradiationProcedure of scaling and root planing and application of 980 nm diode laser at day 0 and at 1 week | Procedure or surgery | 980 nm diode Laser irradiation |
Primary outcome
Change in levels of P.gingivalis
Time frame: 14 weeks
Microbial profile was assessed using PCR at baseline, 4-6 weeks and 12-14 weeks post treatment in both the study groups.
4 secondary outcomes
Change in gingival index
Time frame: 14 weeks
Change in plaque index
Time frame: 14 weeks
Change in probing pocket depth
Time frame: 14 weeks
Change in clinical attachment level
Time frame: 14 weeks
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 2017.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasonic Scaling and root planing and 980 nm diode laser irradiation in people with Chronic Periodontitis, run by KLE Society's Institute of Dental Sciences.
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 2 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: finished, as of the sponsor's last update on 23 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Change in levels of P.gingivalis (time frame: 14 weeks). 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 23 Jan 2017; AzTrials last refreshed its copy on 2 Nov 2026.