Periodontal DiseasesLANAPNCT07798765
Comparative Evaluation of Effect of NSPT With & Without Adjunctive LANAP on OHRQoL: A Randomized Clinical Trial.
A study testing SRP with laser assisted new attachment procedure in people with Periodontal Diseases, run by Mahe Nigar at 1 site in India.
Trial summary
This study compared SRP alone and SRP combined with LANAP in 120 patients with chronic periodontitis. Clinical outcomes and oral health-related quality of life (OHRQoL) were assessed before and 12 weeks after treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Periodontal Diseases
- What is being tested?
- SRP with laser assisted new attachment procedure
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteIndia
- Study dates
- 13 Feb 2024to 30 Apr 2025
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with at least >18 teeth.
- Patients with periodontal pocket depth (PPD) ≥4mm or having ≥3mm clinical attachment loss on at least one of the four surfaces examined.
- Patients with gingival recession defects.
- Patients without occlusal problems or who have received an occlusal correction.
- Patients with no history of periodontal treatment in the last 12 months.
- Patients who are willing to fill out a questionnaire before and after NSPT.
Who cannot join
- Patients with cognitive disorders were unable to answer or interpret the questions.
- Pregnant or lactating women.
- Patients with systemic diseases, including immunosuppression, cardiovascular disease, diabetes mellitus, and blood disorders.
- Patients who took antibiotics or immunosuppressants within the last 6 months.
- Patients with acute illnesses and/or active intraoral lesions.
- Patient having teeth with grade III mobility.
- Patients who were chronic smokers or alcoholics.
- Patients with gingival enlargement or pseudo pockets.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Evaluation Of The Impact Of Scaling & Root Planning With & Without Adjunctive Use Of Laser Assisted New Attachment Procedure On Oral Health Related Quality Of Life In Patients With Periodontitis -A Randomized Clinical Trial
This study compared SRP alone and SRP combined with LANAP in 120 patients with chronic periodontitis. Clinical outcomes and oral health-related quality of life (OHRQoL) were assessed before and 12 weeks after treatment. The study aimed to determine how these treatments affect both periodontal health and patients' quality of life.
Read the detailed description
This study examined two non-surgical treatments for chronic periodontitis, a common inflammatory disease that damages the gums and supporting structures of the teeth and may eventually lead to tooth loss. A total of 120 patients aged 18-65 years were randomly assigned to receive either conventional scaling and root planning (SRP) alone or SRP combined with laser-assisted new attachment procedure (LANAP). Clinical indicators of periodontal health, including gum inflammation, plaque accumulation, pocket depth, and attachment loss, were assessed before treatment and after 12 weeks. The study also evaluated patients' perceptions of their oral health and quality of life using the OHIP-14 questionnaire.
- Conditions
- Periodontal Diseases
- Being tested
- SRP with laser assisted new attachment procedure, Scaling and root planing plus placebo
- Keywords
- LANAP, LASER, OHRQoL, periodontal disease
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SRP with laser assisted new attachment procedureProcedure or surgery
Also called SRP + LANAP
SRP with laser assisted new attachment procedure along with implementation of OHIP 14 to assess oral health related quality of life
Scaling and root planing plus placeboProcedure or surgery
Also called SRP
participants received scaling and root planning with implementation of OHIP 14
| Study group | Role | What they receive |
|---|---|---|
| scaling and root planning only | Active comparator | participants in comparator group only received scaling and root planning treatment Receives: Procedure: Scaling and root planing plus placebo |
| scaling and root planning along with laser assisted new attachment procedure | Experimental | test group received scaling and root planning along with laser assisted new attachment procedure Receives: Procedure: SRP with laser assisted new attachment procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
gingival index
Gingival index scores each site on a 0 to 3 scale, with 0 being normal and 3 being severe inflammation. Clinical examination was performed on the six index teeth. Each of the four surfaces of the teeth (buccal, lingual, mesial and distal) is given a score from 0-3. The scores from the four areas of the tooth were added and divided by four in order to give the GI for the tooth. Finally, by adding the scores for the teeth and dividing by the number of teeth examined, the GI for the individual was obtained
Measured: From enrollment to the end of treatment at 12 weeks
plaque index
Plaque index was calculated as the percentage of teeth with visible plaque on any surface of the tooth. For this, clinical examination was performed on the six index teeth. Each of the four surfaces of the teeth (buccal, lingual, mesial and distal) is given a score from 0-3. The scores from the four areas of the tooth were added and divided by four in order to give the plaque index for the tooth. Plaque index for the individual was obtained by adding the scores for the teeth and dividing by the number of teeth examined
Measured: From enrollment to the end of treatment at 12 weeks
periodontal pocket depth
periodontal pocket depth is the distance between the base of the pocket and gingival margin, measured with a periodontal probe (UNC-15) inserted parallel to the vertical axis of tooth. The measurements were made at four sites per tooth [mesial, buccal, distal and palatal/lingual] for all teeth, excluding third molar.
Measured: From enrollment to the end of treatment at 12 weeks
clinical attachment level
clinical attachment level is the distance between the base of the pocket and a fixed point on crown such as cementoenamel junction. This was assessed using UNC-15 probe from the cementoenamel junction to the base of the pocket at 4 sites [mesial, buccal, distal and palatal/lingual].
Measured: From enrollment to the end of treatment at 12 weeks
Secondary outcomes (1)
OHIP 14
The OHIP-14 questionnaire was administered in its original English version, with a Hindi adaptation provided to facilitate understanding among patients who were not proficient in English. The questionnaire comprises seven dimensions (or domains), each containing two subdomains: functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability, and handicap. Responses were recorded using a Likert scale ranging from 0 to 4, where 0 = never, 1 = hardly ever, 2 = occasionally, 3 = fairly often, and 4 = very often.
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start13 Feb 2024
- Primary completion30 Jan 2025
- Study completion30 Apr 2025
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- This study compared SRP alone with SRP + LANAP in patients with chronic periodontitis.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahe Nigar
- Sponsor type
- University, hospital or other
- Collaborators
- H.P. Government Dental College and Hospital Shimla
- Responsible party
- Sponsor-investigator, Mahe Nigar, H.P. Government Dental College and Hospital Shimla
- Investigators
- Ajay Mahajan, MDS, Study director, HP GDC SHIMLA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07798765
- Sponsor's protocol ID
- NSPT with or without LANAP
- Acronym
- LANAP
- Status last verified
- Aug 2026
- First submitted
- 26 Aug 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only the de-identified individual participant data (IPD) that directly support the results reported in this publication will be considered for sharing. IPD not related to the published analyses will not be included. Data sharing may be limited because the study dataset contains sensitive participant-level clinical and demographic information, and complete sharing could potentially compromise participant privacy and confidentiality, particularly when combined with other available information. Therefore, any sharing of IPD will be subject to appropriate ethical considerations, institutional approval, and applicable informed-consent and data-protection requirements.
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation Of The Impact Of Scaling & Root Planning With & Without Adjunctive Use Of Laser Assisted New Attachment Procedure On Oral Health Related Quality Of Life In Patients With Periodontitis -A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07798765
- Acronym / sponsor ID
- LANAP / NSPT with or without LANAP
- Conditions
- Periodontal Diseases
- Keywords
- LANAP, LASER, OHRQoL, periodontal disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Mahe NigarUniversity, hospital or other
- Collaborators
- H.P. Government Dental College and Hospital Shimla
- Study start
- 13 Feb 2024 (actual)
- Primary completion
- 30 Jan 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 1 Sep 2026 (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 compared SRP alone and SRP combined with LANAP in 120 patients with chronic periodontitis. Clinical outcomes and oral health-related quality of life (OHRQoL) were assessed before and 12 weeks after treatment. The study aimed to determine how these treatments affect both periodontal health and patients' quality of life.
Detailed description
This study examined two non-surgical treatments for chronic periodontitis, a common inflammatory disease that damages the gums and supporting structures of the teeth and may eventually lead to tooth loss. A total of 120 patients aged 18-65 years were randomly assigned to receive either conventional scaling and root planning (SRP) alone or SRP combined with laser-assisted new attachment procedure (LANAP). Clinical indicators of periodontal health, including gum inflammation, plaque accumulation, pocket depth, and attachment loss, were assessed before treatment and after 12 weeks. The study also evaluated patients' perceptions of their oral health and quality of life using the OHIP-14 questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study compared SRP alone with SRP + LANAP in patients with chronic periodontitis.
| Arm | Type | Receives |
|---|---|---|
| scaling and root planning only | Active comparator | Procedure: Scaling and root planing plus placeboparticipants in comparator group only received scaling and root planning treatment |
| scaling and root planning along with laser assisted new attachment procedure | Experimental | Procedure: SRP with laser assisted new attachment proceduretest group received scaling and root planning along with laser assisted new attachment procedure |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with at least >18 teeth.
- Patients with periodontal pocket depth (PPD) ≥4mm or having ≥3mm clinical attachment loss on at least one of the four surfaces examined.
- Patients with gingival recession defects.
- Patients without occlusal problems or who have received an occlusal correction.
- Patients with no history of periodontal treatment in the last 12 months.
Key exclusion criteria (8 listed)
- Patients with cognitive disorders were unable to answer or interpret the questions.
- Pregnant or lactating women.
- Patients with systemic diseases, including immunosuppression, cardiovascular disease, diabetes mellitus, and blood disorders.
- Patients who took antibiotics or immunosuppressants within the last 6 months.
- Patients with acute illnesses and/or active intraoral lesions.
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 |
|---|---|---|
| SRP with laser assisted new attachment procedureAlso: SRP + LANAPSRP with laser assisted new attachment procedure along with implementation of OHIP 14 to assess oral health related quality of life | Procedure or surgery | scaling and root planning along with laser assisted new attachment procedure |
| Scaling and root planing plus placeboAlso: SRPparticipants received scaling and root planning with implementation of OHIP 14 | Procedure or surgery | scaling and root planning only |
Primary outcome
gingival index
Time frame: From enrollment to the end of treatment at 12 weeks
Gingival index scores each site on a 0 to 3 scale, with 0 being normal and 3 being severe inflammation. Clinical examination was performed on the six index teeth. Each of the four surfaces of the teeth (buccal, lingual, mesial and distal) is given a score from 0-3. The scores from the four areas of the tooth were added and divided by four in order to give the GI for the tooth. Finally, by adding the scores for the teeth and dividing by the number of teeth examined, the GI for the individual was obtained
plaque index
Time frame: From enrollment to the end of treatment at 12 weeks
Plaque index was calculated as the percentage of teeth with visible plaque on any surface of the tooth. For this, clinical examination was performed on the six index teeth. Each of the four surfaces of the teeth (buccal, lingual, mesial and distal) is given a score from 0-3. The scores from the four areas of the tooth were added and divided by four in order to give the plaque index for the tooth. Plaque index for the individual was obtained by adding the scores for the teeth and dividing by the number of teeth examined
periodontal pocket depth
Time frame: From enrollment to the end of treatment at 12 weeks
periodontal pocket depth is the distance between the base of the pocket and gingival margin, measured with a periodontal probe (UNC-15) inserted parallel to the vertical axis of tooth. The measurements were made at four sites per tooth [mesial, buccal, distal and palatal/lingual] for all teeth, excluding third molar.
clinical attachment level
Time frame: From enrollment to the end of treatment at 12 weeks
clinical attachment level is the distance between the base of the pocket and a fixed point on crown such as cementoenamel junction. This was assessed using UNC-15 probe from the cementoenamel junction to the base of the pocket at 4 sites [mesial, buccal, distal and palatal/lingual].
1 secondary outcome
OHIP 14
Time frame: From enrollment to the end of treatment at 12 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 1 Sep 2026.
- Individual participant dataSharing planned: No. Only the de-identified individual participant data (IPD) that directly support the results reported in this publication will be considered for sharing. IPD not related to the published analyses will not be included. Data sharing may be limited because the study dataset contains sensitive participant-level clinical and demographic information, and complete sharing could potentially compromise participant privacy and confidentiality, particularly when combined with other available information. Therefore, any sharing of IPD will be subject to appropriate ethical considerations, institutional approval, and applicable informed-consent and data-protection requirements.
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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.
Ajay Mahajan, MDS study director
HP GDC SHIMLA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SRP with laser assisted new attachment procedure in people with Periodontal Diseases, run by Mahe Nigar 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 6 inclusion and 8 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 1 Sep 2026. 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.
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?
gingival index (time frame: From enrollment to the end of treatment at 12 weeks). The study lists 4 primary outcomes in all. 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 1 Sep 2026.