| CTRI Number |
CTRI/2025/07/091129 [Registered on: 18/07/2025] Trial Registered Prospectively |
| Last Modified On: |
17/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Unveiling Phosphatase Shifts following Periodontal Therapy in Current Smokers, former Smokers, and Non-Smokers with Chronic Periodontitis |
|
Scientific Title of Study
|
Comparative Evaluation of Periodontal therapy on Salivary Alkaline Phosphatase and Acid Phosphatase level in Non-smoker and Smoker with Chronic Periodontitis:A Biochemical Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Supriti Dutta |
| Designation |
Post graduate student |
| Affiliation |
Nims Dental College and hospital,Jaipur |
| Address |
Department of Periodontology,Nims Dental Collge and hospital Room no:4
Jaipur
RAJASTHAN
303121
India |
| Phone |
08602725028 |
| Fax |
|
| Email |
dsupriti001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neetha Bhargava |
| Designation |
Head and professor |
| Affiliation |
Nims Dental College and hospital,Jaipur |
| Address |
Department pf periodontology,room no 4, Nims Dental college ,jaipur
Jaipur
RAJASTHAN
303121
India |
| Phone |
08602725028 |
| Fax |
|
| Email |
a82874187@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Supriti Dutta |
| Designation |
Post graduate student |
| Affiliation |
Nims Dental College and hospital,Jaipur |
| Address |
Department of periodontology,Room no 4,Nims dental college and hospital,jaipur
Jaipur
RAJASTHAN
303121
India |
| Phone |
08602725028 |
| Fax |
|
| Email |
dsupriti001@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nims dental college,jaipur |
|
|
Primary Sponsor
|
| Name |
DrSupriti dutta |
| Address |
Ghoretha pg room no:14,shobha nagar ,jaipur-303121 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Supriti Dutta |
Nims Dental College and hospital,Jaipur |
Room no:4,Department of Periodontology,Nims dental college,jaipuur
Jaipur
RAJASTHAN |
08602725028
dsupriti001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instiutional Ethics Committee Nims University Rjasthan,Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Current Smoker, Former smoker, non-smoker with chronic periodontitis |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
distinct participant groups categorized by smoking status. |
In this non-randomized, multi-arm interventional study, the comparator is not a placebo or a different treatment, but rather distinct participant groups categorized by smoking status. All participants received the same intervention (non-surgical periodontal therapy), and outcomes were compared across the following groups:
Group A: Non-smokers with chronic periodontitis (reference group)
Group B: Former smokers with chronic periodontitis
Group C: Current smokers with chronic periodontitis |
| Intervention |
Non-surgical periodontal therapy (NSPT) |
All participants across the three study groups received non-surgical periodontal therapy, which included:
Full-mouth scaling and root planing (SRP) using ultrasonic and hand instruments
Oral hygiene instructions and motivation
No use of antibiotics, antimicrobials, or surgical procedures
The therapy was standardized across all groups and provided by the same clinician to ensure consistency. The effect of this intervention was evaluated through changes in clinical parameters (Gingival Index, Plaque Index, Pocket Probing Depth, Clinical Attachment Level) and salivary biochemical markers (alkaline phosphatase and acid phosphatase levels) at baseline, 15th day, and 4th week. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects unable to provide informed consent or comply with study protocol.
2. Patients with oral potentially malignant disorders and systemic illnesses such as diabetes, hypertension, thyroid or any known endocrine disorders, osteoarthritis, osteosarcoma, and renal failure were excluded.
3. Subjects with presence of fixed prosthesis and orthodontics appliances.
4. Patients presented with systemic disease, pregnant female, lactating or postmenopausal female.
|
|
| ExclusionCriteria |
| Details |
1. Subjects unable to provide informed consent or comply with study protocol.
2. Patients with oral potentially malignant disorders and systemic illnesses such as diabetes, hypertension, thyroid or any known endocrine disorders, osteoarthritis, osteosarcoma, and renal failure were excluded.
3. Subjects with presence of fixed prosthesis and orthodontics appliances.
4. Patients presented with systemic disease, pregnant female, lactating or postmenopausal female.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcomes were changes in alkaline phosphatase (ALP) and acid phosphatase (ACP) levels in saliva following periodontal therapy along with gingival index,plaque index,clinical attachment level and probing depth and comparing before and after result. |
The primary outcomes were changes in alkaline phosphatase (ALP) and acid phosphatase (ACP) levels in saliva following periodontal therapy at baseline,15th day and 4week along with gingival index,plaque index,clinical attachment level and probing depth at baseline and 4weeks and comparing before and after result. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Clinical periodontal parameters including probing pocket depth (PPD), clinical attachment level (CAL), plaque index (PI), & gingival index (GI) were assessed at baseline & at 4week post-treatment to evaluate the clinical effectiveness of periodontal therapy in current smoker,former smoker & non-smoker groups. |
Clinical parameters including probing pocket depth (PPD), clinical attachment level (CAL), gingival index (GI), plaque index (PI) were recorded at baseline (Day 0) & at 4 weeks post-treatment, corresponding with the biochemical follow-up at baseline,15th day & 4week. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
N/A |
|
Date of First Enrollment (India)
|
28/07/2025 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
|
Brief Summary
|
This prospective interventional study aimed to evaluate and compare the effects of non surgical periodontal therapy on clinical and biochemical parameters in individuals with chronic periodontitis stratified by smoking status A total of 60 participants aged 30 50 years were categorized into three groups non smokers Group A former smokers Group B and current smokers Group C Clinical parameters plaque index gingival index probing pocket depth and clinical attachment level were recorded at baseline and at 4 weeks post therapy Unstimulated saliva samples were collected at baseline 15 days and 4 weeks to measure levels of alkaline phosphatase and acid phosphatase using a semi autoanalyzer Non-surgical periodontal therapy will result in significant clinical and biochemical improvement in patients with chronic periodontitis however the extent of improvement will vary with smoking status with non-smokers exhibiting the most favorable response followed by former smokers and current smokers showing the least improvement |