| CTRI Number |
CTRI/2025/11/097897 [Registered on: 24/11/2025] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of Gum Disease Treatment With and Without Laser in Tobacco chewers |
|
Scientific Title of Study
|
Comparative evaluation of scaling and root planing with and without 980nm diode laser assisted new attachment procedure in Stage II Grade B periodontitis among tobacco chewers A Randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrImpanaHA |
| Designation |
PG student |
| Affiliation |
KVG Dental College and Hospital |
| Address |
Room number 11 Department of Periodontology KVG Dental College and Hospital Kurunjibag Sullia Dakshina Kannada Karnataka India
Pincode 574327
Dakshina Kannada
KARNATAKA
574327
India |
| Phone |
9113527309 |
| Fax |
|
| Email |
impanaha99.hsn@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prakash Gurupur Pai |
| Designation |
Professor |
| Affiliation |
KVG Dental College and Hospital |
| Address |
Room number 11 Department of Periodontology KVG Dental College and Hospital Kurunjibag Sullia Dakshina Kannada Karnataka India
Pincode 574327
Dakshina Kannada
KARNATAKA
574327
India |
| Phone |
9845156405 |
| Fax |
|
| Email |
prakashpaipai2014@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prakash Gurupur Pai |
| Designation |
Professor |
| Affiliation |
KVG Dental College and Hospital |
| Address |
Room number 11 Department of Periodontology KVG Dental College and Hospital Kurunjibag Sullia Dakshina Kannada Karnataka India
Pincode 574327
KARNATAKA
574327
India |
| Phone |
9845156405 |
| Fax |
|
| Email |
prakashpaipai2014@gmail.com |
|
|
Source of Monetary or Material Support
|
| KVG Dental College and Hospital Kurunjibag Sullia Dakshina Kannada Karnataka India
Pincode 574327 |
|
|
Primary Sponsor
|
| Name |
Dr Impana H A |
| Address |
Room number 11 Department of Periodontology KVG Dental College and Hospital Kurunjibag Sullia Dakshina Kannada Karnataka India
Pincode 574327 |
| Type of Sponsor |
Other [Self] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Impana H A |
KVG Dental College and Hospital |
Room number 11 Department of
Periodontology KVG Dental College and Hospital Kurunjibag
Sullia Dakshina
Kannada Karnataka
India Pincode 574327
Dakshina Kannada
KARNATAKA
Dakshina Kannada
KARNATAKA |
9113527309
impanaha99.hsn@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KVG Dental College and Hospital |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Scaling and root planing alone |
Thorough Scaling and root planing will be done using ultrasonic scalers and curettes on the other quadrant. Duration of the procedure 30 mins |
| Intervention |
Scaling and root planing with Laser assisted new attachment procedure |
Thorough scaling and root planing will be done using ultasonic scalers and curettes. Diode laser of 980nm is used for performing Laser assisted new attachment procedure in the area of periodontal pocket with curettage mode of laser for 3 mins on one quadrant . Total Duration of the procedure will be 35mins. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients aged 30 to 60 years systemically healthy
2.Patients diagnosed with Stage II Grade B periodontitis with PPD 5 mm CAL 3 mm
3.Patients who are tobacco chewers especially chewing smokeless tobacco for 5 years.
4.Patients with at least 20 natural teeth.
5.No prior scaling root planning or laser therapy in the last 6 months and willing to complete treatment.
6.Patients willing to comply with study procedures and follow up visits.
|
|
| ExclusionCriteria |
| Details |
1.Patients with systemic conditions affecting periodontal health .
2.Patients on medications known to affect periodontal healing .
3.Presence of Stage III or IV periodontitis
4.Patients who have received periodontal treatment within the last 6 months.
5.Patients with active orthodontic treatment or patients with a history of substance abuse
6.Patients with a history of laser treatment in the oral cavity.
|
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
| To compare the outcomes of SRP alone versus SRP combined with LANAP in tobacco-chewing patients. |
baseline and after 1 month, 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| • To measure clinical periodontal parameters like probing depth, clinical attachment level, bleeding on probing before and after treatment. |
baseline and after 1 month, 3 months |
|
|
Target Sample Size
|
Total Sample Size="8"
Sample Size from India="8"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
06/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
Periodontal
disease forms a major part of the worldwide oral health burden and is closely
linked with risk factors that are also associated with many chronic systemic
conditions . Periodontitis
ranks among the most prevalent dental diseases, resulting in progressive damage
to the tooth-supporting and surrounding tissues. The term "periodontitis"
is build up of two words, i.e., "periodont-" meaning "structure
surrounding the teeth" and "itis" means
"inflammation." Periodontitis begins as an inflammatory condition
confined to the gingiva, but when left unmanaged, the process extends into the
deeper periodontal structures, disrupts bone balance, and may ultimately lead
to tooth loss. Periodontal
disease has a multifactorial origin. The course of the disease is largely influenced by
the host immune response; however, local irritants such as plaque and calculus,
genetic predisposition, systemic health status, environmental exposures,
lifestyle practices, and broader social determinants also contribute to its
progression.
Tobacco chewing—which includes smokeless
products such as gutkha, betel quid with tobacco, and other forms—is linked to
significant systemic health risks, even beyond oral pathology. A recent
meta-analysis found that individuals who chew tobacco face elevated risks of
head and neck cancers, including cancers of the lip and oral cavity, as well as
esophageal and pharyngeal cancers. The deleterious effects of
tobacco chewing on the periodontium are well established. Clinical
investigations consistently report deeper periodontal pockets, greater
attachment loss, and increased gingival recession in tobacco chewers compared
with non-users .the inclusion of tobacco chewers in the study allows for the exploration
of whether laser-assisted therapy can counteract the detrimental effects of
tobacco use on periodontal tissues. This study could also provide insights into
patient-reported outcomes, including comfort and satisfaction with
laser-assisted treatment, which are important considerations in clinical
practice.
The findings from this research have the potential to contribute
significantly to evidence-based periodontal therapy. If laser-assisted therapy
is shown to be effective in tobacco chewers, it could lead to the development
of tailored treatment protocols, improving outcomes for a population with
historically poor responses to conventional therapies. Furthermore, this study
may help bridge the existing gap in literature regarding the role of lasers in
high-risk populations, thereby advancing periodontal clinical practice.
This study is needed to evaluate the adjunctive use of a 980 nm diode
laser with SRP in the treatment of stage II grade B periodontitis among tobacco
chewers. The results will provide high-quality evidence regarding its efficacy,
inform clinical decision-making, and potentially improve outcomes for patients
who face unique challenges in achieving periodontal health.
|