| CTRI Number |
CTRI/2026/01/101637 [Registered on: 20/01/2026] Trial Registered Prospectively |
| Last Modified On: |
19/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Evaluate the Effect of Photodynamic Therapy along with Scaling and Root Planing on Type 2 Diabetes Mellitus Patients with Chronic Periodontitis by Clinical and Biochemical methods |
|
Scientific Title of Study
|
Effect of Photodynamic Therapy with Scaling and Root Planing on Type 2 Diabetes Mellitus Status in Chronic Periodontitis Patients: A Clinico-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 Priyanshi Sachan |
| Designation |
postgraduate |
| Affiliation |
Uttar Pradesh University of Medical Sciences |
| Address |
Room no 424, Department of Periodontology, Faculty of Dental Sciences, Uttar Pradesh University of Medical Sciences
Etawah
UTTAR PRADESH
206130
India |
| Phone |
8171773082 |
| Fax |
|
| Email |
sachanpriyanshi09@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bipin Kumar Yadav |
| Designation |
Professor |
| Affiliation |
Uttar Pradesh University of Medical Sciences |
| Address |
Department of Periodontology, Faculty of Dental Sciences, Uttar Pradesh University of Medical Sciences, Saifai, Etawah, Uttar Pradesh
Etawah
UTTAR PRADESH
206130
India |
| Phone |
8449619482 |
| Fax |
|
| Email |
drbipinyadav@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bipin Kumar Yadav |
| Designation |
Professor |
| Affiliation |
Uttar Pradesh University of Medical Sciences |
| Address |
Department of Periodontology, Faculty of Dental Sciences, Uttar Pradesh University of Medical Sciences, Saifai, Etawah, Uttar Pradesh
Etawah
UTTAR PRADESH
206130
India |
| Phone |
8449619482 |
| Fax |
|
| Email |
drbipinyadav@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Periodontology, Faculty of dental sciences, Uttar Pradesh University of dental sciences, Saifai, Etawah, Uttar Pradesh, India |
|
|
Primary Sponsor
|
| Name |
Dr Priyanshi Sachan |
| Address |
D- 203, Swami Vivekananda hostel, new campus, Uttar Pradesh University of Medical Sciences, Saifai, Etawah, Uttar Pradesh pincode - 206130 |
| 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 Priyanshi Sachan |
Uttar Pradesh University of Medical Sciences |
room no - 424, Department of
Periodontology, Faculty of dental sciences, Uttar Pradesh
University of Medical Sciences, Saifai, Etawah, Uttar Pradesh
Etawah
UTTAR PRADESH |
08171773082
Sachanpriyanshi09@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical committee, Uttar Pradesh University of dental sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Scaling and root planing |
only full mouth scaling and root planing done |
| Intervention |
scaling and root planing with Photodynamic therapy. |
Full mouth scaling and root planing will be done
within 2 consecutive days and Photodynamic Therapy will be given after Scaling and root planing |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient with Stage II – III Grade B chronic periodontitis.
Type 2 diabetic patients with an HbA1c level of more than or equal to 6.5 %. |
|
| ExclusionCriteria |
| Details |
Patient who had undergone periodontal, antibiotic, or photodynamic treatment in
the last 30 days.
Pregnant or lactating women.
Smokers, Alcoholics
History of allergic to dye |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Fractalkine (CX3CL1) in Serum
and HbA1c level in blood |
Fractalkine and HbA1c - Before scaling and root planing and after 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Plaque index, Gingival index, Probing pocket depth, Clinical attachment level |
Before scaling and root planing and after 3 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
17/02/2026 |
| 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)
|
Not Yet Recruiting |
| 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
|
BACKGROUND: Periodontitis is a chronic inflammatory disease of the periodontium caused
by oral microbiota that destroy the periodontium. The subgingival microbiota and immune
inflammatory response of the host is responsible for triggering inflammation in periodontitis.
The conventional treatment, scaling and root planing remains primary non-surgical
management of chronic periodontitis. Various methods are constantly employed to improve the
effects of non-surgical treatment, including photodynamic therapy (PDT).
PDT is based on chemicals called photosensitizers that are activate by specific light
wavelength. Its activation leads to the generation of singlet oxygen and free radicals responsible
for cytotoxic effect against bacterial cells.
NOVELTY: PDT is a newer advent in laser and it is beneficial when used as an adjunct to
periodontal therapy due to its antibacterial property. In most studies, only clinical parameters
are taken into consideration but in present study, Fractalkine levels are measured as a
biochemical marker for evaluation. Fractalkine, a chemokine marker is one of the new possible
biomarkers for periodontal disease and type 2 diabetes mellitus.
OBJECTIVE: To assess the effect of photodynamic therapy with SRP in type 2 diabetes
mellitus of chronic periodontitis with the help of clinical parameters, biochemical parameters
using fractalkine level in serum, HbA1c level.
METHODOLOGY: Patients will be selected as per inclusion and exclusion criteria. Full
mouth SRP will be done. Subgingival placement of dye and allowed remain inside for
60seconds. The pocket surface was then exposed to diode laser for 1minute/tooth (10seconds
for each of site). Clinical parameters which include PI, GI, PPD, CAL and biochemical
parameter HbA1c will be measured at baseline and after 3 months along with collection of
serum for evaluation of Fractalkine (CX3CL1).
EXPECTED OUTCOMES: The present study expects more reduction in inflammation on
sites treated with PDT with SRP as compared to SRP alone in type 2 diabetic patients of chronic
periodontitis. |