PeriodontitisNCT03365167
Clinical Evaluation of the Effect of LANAP as an Adjunct Treatment in Management of Patients With Chronic Periodontitis
A study testing LANAP (Laser Assisted New Attachment Procedure) and LANAP off in people with Periodontitis and Laser, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial summary
this study evaluate the effect of LANAP (Laser Assisted New Attachment Procedure) as an Adjunct Treatment in Management of Patients With Chronic Periodontitis and assay the effect of LANAP on periodontal indexes like BOP, CAL, probing depth Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Laser
- What is being tested?
- LANAP (Laser Assisted New Attachment Procedure) and LANAP off
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteIran
- Study dates
- 30 Dec 2017to 30 Mar 2019
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- definite diagnosis of chronic periodontitis with at least two teeth with periodontal pocket depth more than 4 mm in each side
Who cannot join
- pregnant smoker systemic disease breast feeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of the Effect of LANAP (Laser Assisted New Attachment Procedure) as an Adjunct Treatment in Management of Patients With Chronic Periodontitis( Randomized Clinical Trial Study)
this study evaluate the effect of LANAP (Laser Assisted New Attachment Procedure) as an Adjunct Treatment in Management of Patients With Chronic Periodontitis and assay the effect of LANAP on periodontal indexes like BOP, CAL, probing depth
Read the detailed description
this study evaluate the effect of LANAP (Laser Assisted New Attachment Procedure) as an Adjunct Treatment in Management of Patients With Chronic Periodontitis and assay the effect of LANAP on periodontal indexes like BOP, CAL, probing depth in a split mouth design before treatment and after follow up sessions.
- Conditions
- Periodontitis, Laser
- Being tested
- LANAP (Laser Assisted New Attachment Procedure), LANAP off
- Keywords
- LANAP, Periodontitis
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LANAP (Laser Assisted New Attachment Procedure)Radiation
radiation of Nd:YAG laser in periodontal pocket
LANAP offRadiation
radiation of Nd:YAG laser in off mode in periodontal pocket
| Study group | Role | What they receive |
|---|---|---|
| LANAP | Active comparator | LANAP (Laser Assisted New Attachment Procedure) Receives: Radiation: LANAP (Laser Assisted New Attachment Procedure) |
| LANAP off | Placebo comparator | laser therapy in off mode Receives: Radiation: LANAP off |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of periodontal pocket depth
depth of periodontal pocket of each tooth
Measured: 0,1,2,3,4,5,6 months
Secondary outcomes (4)
change of Bleeding on Probing
sign of bleeding after 1 minutes post probing the tooth pocket
Measured: 0,1,2,3,4,5,6 month
change of Full Mouth Bleeding Score
Bleeding Score of all teeth that is calculated by counting the Four dental levels that have sign of bleeding post probing (including , mesio-buccal,mid- buccal, disto-buccal and lingual) divided by the total number of total teeth in the mouth *4
Measured: 0,1,2,3,4,5,6 month
change of Clinical attachment loss
distance from depth of tooth sulcus to cemento-enamel junction
Measured: 0,1,2,3,4,5,6 month
change of Full Mouth Plaque Score
the number of 4 surfaces of each tooth(mesiobuccal, mid buccal, disto buccal and lingual surfaces) that have plaque that is disclosed by disclosing tables , then counting the number of the colored surface of all teeth divided by the total number of total teeth in the mouth*4
Measured: 0,1,2,3,4,5,6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2017
- Study start30 Dec 2017
- Primary completion1 Mar 2019
- Study completion30 Mar 2019
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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neda Moslemi, Tehran University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03365167
- Sponsor's protocol ID
- 96-02-97-36092
- Status last verified
- Feb 2021
- First submitted
- 25 Oct 2017
- Last updated
- 3 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dortaj D, Bassir SH, Hakimiha N, Hong H, Aslroosta H, Fekrazad R, Moslemi N. Efficacy of Nd:YAG laser-assisted periodontal therapy for the management of periodontitis: A double-blind split-mouth randomized controlled clinical trial. J Periodontol. 2022 May;93(5):662-672. doi: 10.1002/JPER.21-0242. Epub 2021 Sep 12.
PubMed 34411291
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Effect of LANAP (Laser Assisted New Attachment Procedure) as an Adjunct Treatment in Management of Patients With Chronic Periodontitis( Randomized Clinical Trial Study)
- ClinicalTrials.gov ID
- NCT03365167
- Acronym / sponsor ID
- 96-02-97-36092
- Conditions
- Periodontitis, Laser
- Keywords
- LANAP, Periodontitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- 30 Dec 2017 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 30 Mar 2019 (actual)
- First posted
- 7 Dec 2017 (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.
this study evaluate the effect of LANAP (Laser Assisted New Attachment Procedure) as an Adjunct Treatment in Management of Patients With Chronic Periodontitis and assay the effect of LANAP on periodontal indexes like BOP, CAL, probing depth
Detailed description
this study evaluate the effect of LANAP (Laser Assisted New Attachment Procedure) as an Adjunct Treatment in Management of Patients With Chronic Periodontitis and assay the effect of LANAP on periodontal indexes like BOP, CAL, probing depth in a split mouth design before treatment and after follow up sessions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LANAP | Active comparator | Radiation: LANAP (Laser Assisted New Attachment Procedure)LANAP (Laser Assisted New Attachment Procedure) |
| LANAP off | Placebo comparator | Radiation: LANAP offlaser therapy in off mode |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- definite diagnosis of chronic periodontitis with at least two teeth with periodontal pocket depth more than 4 mm in each side
Key exclusion criteria (1 listed)
- pregnant smoker systemic disease breast feeding
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 |
|---|---|---|
| LANAP (Laser Assisted New Attachment Procedure)radiation of Nd:YAG laser in periodontal pocket | Radiation | LANAP |
| LANAP offradiation of Nd:YAG laser in off mode in periodontal pocket | Radiation | LANAP off |
Primary outcome
change of periodontal pocket depth
Time frame: 0,1,2,3,4,5,6 months
depth of periodontal pocket of each tooth
4 secondary outcomes
change of Bleeding on Probing
Time frame: 0,1,2,3,4,5,6 month
change of Full Mouth Bleeding Score
Time frame: 0,1,2,3,4,5,6 month
change of Clinical attachment loss
Time frame: 0,1,2,3,4,5,6 month
change of Full Mouth Plaque Score
Time frame: 0,1,2,3,4,5,6 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 3 Mar 2021.
- Derived from this study: PubMed 34411291Dortaj D, Bassir SH, Hakimiha N, Hong H, Aslroosta H, Fekrazad R, Moslemi N. Efficacy of Nd:YAG laser-assisted periodontal therapy for the management of periodontitis: A double-blind split-mouth randomized controlled clinical trial. J Periodontol. 2022 May;93(5):662-672. doi: 10.1002/JPER.21-0242. Epub 2021 Sep 12.
- Individual participant dataSharing planned: No
Related trials for Periodontitis
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
Active, not recruitingObservational study
A Retrospective Comparative Evaluation of Omega-3 and Resveratrol Supplementation in Patients With Periodontitis
Periodontitis
Recruiting
Probiotics Versus Antibiotics as an Adjuvant to Non-surgical Periodontal Treatment Among Smokers With Stage II, Grade B Periodontitis
Probiotics, Antibiotics
Recruiting
Effects of Different Activation Techniques on Antimicrobial Photodynamic Therapy in Apical Periodontitis
Apical Periodontitis, Endodontic Retreatment
Recruiting
Ozone Gel Versus Chlorohexidine Gel as an Adjunct to Non-Surgical Treatment of Stage II Periodontitis Grade B Among Smokers Patients
Ozone Gel, Chlorohexidine Gel
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 study testing LANAP (Laser Assisted New Attachment Procedure) and LANAP off in people with Periodontitis and Laser, run by Tehran University of Medical Sciences at 1 site in Iran.
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 3 Mar 2021. 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 Iran. 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. Some participants in this study may receive a placebo. 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 of periodontal pocket depth (time frame: 0,1,2,3,4,5,6 months). 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 NCT03365167, 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 3 Mar 2021.