| CTRI Number |
CTRI/2018/09/015737 [Registered on: 17/09/2018] Trial Registered Prospectively |
| Last Modified On: |
24/08/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Influence of photodynamic therapy (diode laser) as an adjunct to scaling and root planing on the levels of Gingival Crevicular Fluid (GCF) Interleukin-6, 8 & 10 in the treatment of chronic periodontitis. |
|
Scientific Title of Study
|
Effect of Photodynamic Therapy as an adjunct to Non-Surgical Periodontal Therapy on Gingival Crevicular Fluid (GCF) Interleukin-6, Interleukin-8 & Interleukin-10 Levels in Chronic Periodontitis: A Randomized Controoled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vishakha Kharkar |
| Designation |
P.G. Student |
| Affiliation |
VSPM Dental College & Research Centre, Nagpur |
| Address |
Dept. of Periodontics & Implantology,
VSPM Dental College & Research Centre,
Digdoh Hills, Hingna Road
Nagpur
Digdoh Hills, Hingna Road
Nagpur
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9730753400 |
| Fax |
|
| Email |
vishakhakharkar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhay P Kolte |
| Designation |
Prof. and Guide, HOD |
| Affiliation |
VSPM Dental College & Research Centre, Nagpur |
| Address |
Dept. of Periodontics & Implantology,
VSPM Dental College & Research Centre,
Digdoh Hills, Hingna Road
Nagpur
Digdoh Hills, Hingna Road
Nagpur
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9011071467 |
| Fax |
|
| Email |
drabhaypkolte@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhay P Kolte |
| Designation |
Prof. and Guide, HOD |
| Affiliation |
VSPM Dental College & Research Centre, Nagpur |
| Address |
Dept. of Periodontics & Implantology,
VSPM Dental College & Research Centre,
Digdoh Hills, Hingna Road
Nagpur
Digdoh Hills, Hingna Road
Nagpur
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9011071467 |
| Fax |
|
| Email |
drabhaypkolte@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept. of Periodontics & Implantology,
VSPM Dental College & Research Centre,
Digdoh Hills, Hingna Road
Nagpur -440019
Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
None |
| Address |
None |
| Type of Sponsor |
Other [None] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vishakha Kharkar |
NKP Salve Institute of Medical Sciences |
Dept of biochemistry
Digdoh Hills Hingna Road
Nagpur-440019
Nagpur
MAHARASHTRA |
9730753400
vishakhakharkar@gmail.com |
| Dr Vishakha Kharkar |
VSPM Dental College & Research Centre |
Room No-104 Dept of Periodontics & Implantology Digdoh Hills Hingna Road
Nagpur-440019
Nagpur
MAHARASHTRA |
9730753400
vishakhakharkar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| VSPM Dental College and Research Centre Ethics Committee. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Chronic periodontitis |
| Patients |
(1) ICD-10 Condition: V00-Y99||External causes of morbidity, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
GCF Interleukin-6, Interleukin-8, and Interleukin-10 will be evaluated at baseline and 3 months in chronic periodontitis |
Improvement in GCF levels of Interleukin-6, Interleukin-8, and Interleukin-10 are evaluated in chronic periodontitis patients undergoing Non-Surgical Periodontal therapy along with Photodynamic therapy in 3 months. |
| Intervention |
Non surgical periodontal therapy and photodynamic therapy |
Improvement in periodontal status i.e reduction in probing pocket depth and gain in clinical attachment level in chronic periodontitis patients undergoing Non-Surgical Periodontal therapy along with Photodynamic therapy at 1 and 3 months |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Gingival Index (GI)>1; Probing Depth (PD)> 5mm and Clinical Attachment Loss (CAL)> 3mm with alveolar bone loss affecting > 30% of the teeth as detected on radiograph at the time of initial diagnosis, based on the classification by American Academy of Periodontology, 1999. |
|
| ExclusionCriteria |
| Details |
1. Patients with medical disorders such as cardiovascular or renal disease, etc.
2. Patients with recent history or presence of acute or chronic infection.
3. Individuals with history of tobacco chewing and smoking.
4. Pregnant and lactating females.
5. Patients with history of periodontal therapy or antibiotic treatment or any other anti-inflammatory medication within previous 6 months.
6. Patients with history of poorly controlled diabetes, liver diseases, malignancy, radiotherapy, or allergy to toluidine blue.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in GCF levels of Interleukin-6, Interleukin-8, and Interleukin-10 are evaluated in chronic periodontitis patients undergoing Non-Surgical Periodontal therapy along with Photodynamic therapy in 3 months. |
3 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in periodontal status i.e reduction in probing pocket depth and gain in clinical attachment level in chronic periodontitis patients undergoing Non-Surgical Periodontal therapy along with Photodynamic therapy at 1 and 3 months |
3 months |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
17/09/2018 |
| Date of Study Completion (India) |
15/10/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Aim: To evaluate the effect of photodynamic
therapy (PDT) as an adjunct to non-surgical periodontal therapy (NSPT) on levels of
gingival crevicular fluid (GCF) Interleukin-6 (IL-6), Interleukin-8 (IL-8), and
Interleukin-10 (IL-10) in chronic periodontitis (CP) patients. Materials and methods: A total of 20 participants with age
above 35 years of age including both male and female were recruited and
was divided into 2 Groups- Group I: CP patients undergoing NSPT alone. Group II: CP
patients undergoing NSPT along with PDT. Periodontal parameters including Plaque
index, gingival index, Probing pocket depth, Clinical Attachment loss were recorded
at baseline, 1month and 3 months. GCF samples were collected from contralateral
premolars and molars at baseline and 3month and were evaluated using ELISA kit. NSPT was
performed with or without PDT at the contralateral premolars and molars, at baseline and 1
month. Results : Statistically significant difference
was found at 1 and 3 months with respect to clinical parameters i.e. PI,GI,
BOP, PPD, CAL and biochemical parameters in both the groups.
Conclusion: Both treatment modalities proved to be
beneficial in reducing inflammation in chronic periodontitis patients. |