Periodontal DiseasesNCT01215201
Diode Laser Study for Periodontal Maintenance Patients
A study testing Scaling and Root Planing and Diode Laser + Scaling and Root Planing in people with Periodontal Diseases and Periodontitis, Apical, Chronic Nonsuppurative, run by University of Nebraska at 1 site in United States.
Trial summary
This study tries to determine whether the additional use of laser with "cleaning" (known as scaling and root planning) will result in the reduction of inflammation, reduction of bleeding upon examination and reduction of pocket depth in patients who are being maintained on a regular basis but have pocket depths that… Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Periodontal Diseases, Periodontitis, Apical, Chronic Nonsuppurative, Suppuration of Gingival Crevice
- What is being tested?
- Scaling and Root Planing and Diode Laser + Scaling and Root Planing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2010to 1 Jul 2011
- 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
- Any adult periodontal maintenance patient having had chronic periodontitis with last active therapy at least 3 months prior and with 1 or more sites/subject with ≥5mm probing depth that have bleeding on probing and/or suppuration. They have signed an informed consent form to participate in the study.
Who cannot join
- Subjects who are un-controlled diabetics, use NSAIDS regularly for chronic disease/pain, used antibiotics for the last 3 months, require antibiotic coverage for therapy, are pregnant and below age 30.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center, College of Dentistry
Lincoln, Nebraska, 68583
About this study
Official title: Adjunctive Non-Surgical Therapy of Inflamed Periodontal Pockets Using Diode Lasers During Maintenance Therapy
This study tries to determine whether the additional use of laser with "cleaning" (known as scaling and root planning) will result in the reduction of inflammation, reduction of bleeding upon examination and reduction of pocket depth in patients who are being maintained on a regular basis but have pocket depths that are ≥5mm with bleeding. When a pocket is bleeding, it is inflamed. It is usually "cleaned" with periodontal instruments (root-planed) to establish health. Some research also advocates using laser therapy to treat a bleeding pocket. Laser therapy is presently being performed in some dental offices and dental colleges. This research is trying to see if the additional laser therapy is beneficial.
Read the detailed description
The purpose of this study is to determine whether the adjunctive use of diode laser with scaling and root planing is more effective than scaling and root planing alone in clinically reducing periodontal pocket depth (PD), reducing bleeding on probing (BOP) and gaining of clinical attachment level (CAL). It also assesses whether diode laser with scaling and root planing will have an effect on cytokines and inflammatory biomarkers compared to root planing alone.
Any adult who is currently a routine periodontal maintenance patient and has one or more ≥ 5mm pockets with BOP will be invited to participate in the study. If they choose to participate, they will sign an informed consent. Crevicular fluid samples from each test site and another non-involved site in the mouth will be collected utilizing the standard protocol and frozen for later analyses of the presence of certain inflammatory biomarkers (IL-1β). Baseline data (i.e., PD, CAL, BOP, suppuration, supragingival plaque, subgingival restorative margins, smoking status) will be collected. The involved teeth will then be randomly treated with scaling and root-planing with hand instruments and diode laser (test) or scaling and root-planing with hand instruments alone. The patient will return 3 months later for follow-up data collection. He/she will then receive his/her regular 3 month maintenance therapy.
The changes between baseline and 3 months for the clinical parameters and gingival crevicular fluids' inflammatory biomarkers will be compared between test and control experimental sites.
- Conditions
- Periodontal Diseases, Periodontitis, Apical, Chronic Nonsuppurative, Suppuration of Gingival Crevice
- Being tested
- Scaling and Root Planing, Diode Laser + Scaling and Root Planing
- Keywords
- Periodontal maintenance, ≥5mm probing depth, bleeding on probing and/or suppuration
- Medical subject headings
- Periodontal Diseases, Periapical Granuloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scaling and Root PlaningProcedure or surgery
Use periodontal hand instruments (curettes) to remove plaque, bacteria, and deposits on the root's surfaces.
Diode Laser + Scaling and Root PlaningProcedure or surgery
First: Periodontal hand instruments (curettes) were used to remove plaque, bacteria, and deposits on the root's surfaces (within a periodontal pocket) Then: Biolase 940 nm Ezlase diode laser was used to sterilize a periodontal pocket. Power: 0.80 Watts Wavelength: 940 nm Energy level: 0.80 Joules/second Mode of beam delivery: continuous
| Study group | Role | What they receive |
|---|---|---|
| Scaling and Root Planing Alone | Other | Control group Receives: Procedure: Scaling and Root Planing |
| Diode Laser plus Scaling and Root Planing | Experimental | Diode Laser is used in addition to Scaling and root planing procedure. Receives: Procedure: Diode Laser + Scaling and Root Planing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periodontal clinical parameters
Reduction in Probing Depth, Gaining of clinical attachment level, Reduction of Bleeding upon Probing, Reduction of Plaque accumulation, reduction of IL-1B inflammatory marker.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2010 (estimated)
- Study start1 May 2010
- Primary completion1 Jun 2011
- Study completion1 Jul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Naomi-Trang Nguyen, DDS, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01215201
- Sponsor's protocol ID
- 0452-09-EP
- Status last verified
- Sep 2023
- First submitted
- 4 Oct 2010
- Last updated
- 15 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjunctive Non-Surgical Therapy of Inflamed Periodontal Pockets Using Diode Lasers During Maintenance Therapy
- ClinicalTrials.gov ID
- NCT01215201
- Acronym / sponsor ID
- 0452-09-EP
- Conditions
- Periodontal Diseases, Periodontitis, Apical, Chronic Nonsuppurative, Suppuration of Gingival Crevice
- Keywords
- Periodontal maintenance, ≥5mm probing depth, bleeding on probing and/or suppuration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 1 May 2010 (actual)
- Primary completion
- 1 Jun 2011 (actual)
- Study completion
- 1 Jul 2011 (actual)
- First posted
- 6 Oct 2010 (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.
This study tries to determine whether the additional use of laser with "cleaning" (known as scaling and root planning) will result in the reduction of inflammation, reduction of bleeding upon examination and reduction of pocket depth in patients who are being maintained on a regular basis but have pocket depths that are ≥5mm with bleeding. When a pocket is bleeding, it is inflamed. It is usually "cleaned" with periodontal instruments (root-planed) to establish health. Some research also advocates using laser therapy to treat a bleeding pocket. Laser therapy is presently being performed in some dental offices and dental colleges. This research is trying to see if the additional laser therapy is beneficial.
Detailed description
The purpose of this study is to determine whether the adjunctive use of diode laser with scaling and root planing is more effective than scaling and root planing alone in clinically reducing periodontal pocket depth (PD), reducing bleeding on probing (BOP) and gaining of clinical attachment level (CAL). It also assesses whether diode laser with scaling and root planing will have an effect on cytokines and inflammatory biomarkers compared to root planing alone.
Any adult who is currently a routine periodontal maintenance patient and has one or more ≥ 5mm pockets with BOP will be invited to participate in the study. If they choose to participate, they will sign an informed consent. Crevicular fluid samples from each test site and another non-involved site in the mouth will be collected utilizing the standard protocol and frozen for later analyses of the presence of certain inflammatory biomarkers (IL-1β). Baseline data (i.e., PD, CAL, BOP, suppuration, supragingival plaque, subgingival restorative margins, smoking status) will be collected. The involved teeth will then be randomly treated with scaling and root-planing with hand instruments and diode laser (test) or scaling and root-planing with hand instruments alone. The patient will return 3 months later for follow-up data collection. He/she will then receive his/her regular 3 month maintenance therapy.
The changes between baseline and 3 months for the clinical parameters and gingival crevicular fluids' inflammatory biomarkers will be compared between test and control experimental sites.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Scaling and Root Planing Alone | Other | Procedure: Scaling and Root PlaningControl group |
| Diode Laser plus Scaling and Root Planing | Experimental | Procedure: Diode Laser + Scaling and Root PlaningDiode Laser is used in addition to Scaling and root planing procedure. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any adult periodontal maintenance patient having had chronic periodontitis with last active therapy at least 3 months prior and with 1 or more sites/subject with ≥5mm probing depth that have bleeding on probing and/or suppuration. They have signed an informed consent form to participate in the study.
Key exclusion criteria (1 listed)
- Subjects who are un-controlled diabetics, use NSAIDS regularly for chronic disease/pain, used antibiotics for the last 3 months, require antibiotic coverage for therapy, are pregnant and below age 30.
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 |
|---|---|---|
| Scaling and Root PlaningUse periodontal hand instruments (curettes) to remove plaque, bacteria, and deposits on the root's surfaces. | Procedure or surgery | Scaling and Root Planing Alone |
| Diode Laser + Scaling and Root PlaningFirst: Periodontal hand instruments (curettes) were used to remove plaque, bacteria, and deposits on the root's surfaces (within a periodontal pocket) Then: Biolase 940 nm Ezlase diode laser was used to sterilize a periodontal pocket. Power: 0.80 Watts Wavelength: 940 nm Energy level: 0.80 Joules/second Mode of beam delivery: continuous | Procedure or surgery | Diode Laser plus Scaling and Root Planing |
Primary outcome
Periodontal clinical parameters
Time frame: 3 months
Reduction in Probing Depth, Gaining of clinical attachment level, Reduction of Bleeding upon Probing, Reduction of Plaque accumulation, reduction of IL-1B inflammatory marker.
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 15 Sep 2023.
Related trials for Periodontal Diseases
RecruitingObservational study
Effects Of Periodontal Therapy In Patients With Inflammatory Bowel Disease
Periodontal Diseases, IBD
Not yet recruiting
Effect of Customized Versus Stock Healing Abutments on Peri-Implant Soft Tissue
Peri-Implantitis
Not yet recruitingPhase 3
Periodontal Disease and Small Vulnerable Newborns in Rural Nepal: A Community-based Trial
Preterm Birth, Low Birth Weight
Active, not recruitingObservational study
A Retrospective Cohort Study on the Non-Surgical Treatment of Periapical Inflammatory Lesions With Vitapex Paste
Periapical Periodontitis, Periapical Abscess
Not yet recruitingObservational study
Diagnostic Accuracy of Large Language Models for Peri-Implant Marginal Bone Loss on Panoramic Radiographs
Peri-implantitis, Alveolar Bone Loss
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.
Naomi-Trang Nguyen, DDS principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scaling and Root Planing and Diode Laser + Scaling and Root Planing in people with Periodontal Diseases and Periodontitis, Apical, Chronic Nonsuppurative, run by University of Nebraska at 1 site in United States.
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 1 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 15 Sep 2023. 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 United States. 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?
Periodontal clinical parameters (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 15 Sep 2023.