| CTRI Number |
CTRI/2025/04/084046 [Registered on: 03/04/2025] Trial Registered Prospectively |
| Last Modified On: |
27/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Combined effects of Laser along with Blood component in the treatment of Gum Disease |
|
Scientific Title of Study
|
Synergistic effects of Photobiomodulation and Titanium Reinforced Platelet Rich Fibrin in the treatment of Intrabony defects -A Randomized Controlled Clinical 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 |
Battula Priyanka |
| Designation |
Post Graduate Student |
| Affiliation |
Vishnu Dental College |
| Address |
Block 2, Room no.7, Department of Periodontics, Vishnupur, Bhimavaram
Department of Periodontics, Vishnupur, Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9182954147 |
| Fax |
08816250894 |
| Email |
priyankabattula071@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mohan Kumar P |
| Designation |
Associate professor |
| Affiliation |
Vishnu Dental College |
| Address |
Block 2, Room no.7, Department of Periodontics, Vishnupur, Bhimavaram
Department of Periodontics, Vishnupur, Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
7799411140 |
| Fax |
08816250894 |
| Email |
mosups@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mohan Kumar P |
| Designation |
Associate professor |
| Affiliation |
Vishnu Dental College |
| Address |
Block 2, Room no.7, Department of Periodontics, Vishnupur, Bhimavaram
Department of Periodontics, Vishnupur, Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
7799411140 |
| Fax |
08816250894 |
| Email |
mosups@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vishnu Dental college, Vishnupur, Bhimavaram, West Godavari, Andhra Pradesh, India, Postal code - 534202 |
|
|
Primary Sponsor
|
| Name |
Dr Battula Priyanka |
| Address |
Block 2, Room no.7, Department of Periodontics, Vishnu Dental College, Vishnupur, Bhimavaram |
| 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 Battula Priyanka |
Vishnu Dental College |
Block 2, Room No.7, Department of Periodontics, Vishnu Dental College, Vishnupir, Bhimavaram, West Godavari, Andhra Pradesh, India, Postal Code- 534202
West Godavari
ANDHRA PRADESH |
9182954147
08816250894
priyankabattula071@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Vishnu Dental College |
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 |
| Intervention |
Photobiomodulation along with T-PRF |
After Flap elevation, Defect will be irradiated with PBM using 810nm diode laser, 0.1W power, irradiated for 30 seconds for 3 times( total time - 90 seconds).T-PRF will be placed into the intrabony defect . Post operatively the site is irradiated with PBM therapy using 810nm diode laser, 0.1W power, irradiated for 30 seconds for 3 times( total time - 90 seconds)in one day.Patient will be recalled after 1 week 3months and 6 months.
|
| Comparator Agent |
T-PRF Alone |
After Flap Elevation , T-PRF will be placed into the defect site followed by suturing. Patient will be recalled after 1 week,3months and 6 months. |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.3-walled intrabony defects having a radiological vertical bone loss of greater than or equal to 3mm with a persistent probing depth of greater than or equal to 5mm after non surgical therapy
2.Evidence of greater than or equal to 3mm of Intrabony depth defect
3.Intrabony defect angle of 37-40 degrees.
4.Non smokers
|
|
| ExclusionCriteria |
| Details |
ASA-III,IV,V
Patients undergoing Bis-phosphonate therapy
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Early healing Index(HI) (Wachtel et al.2003)
2.Probing pocket depth (PPD) using UNC 15 probe
3.Clinical attachment loss (CAL)
4.Linear amount of bone fill
5.Percentage bone fill
6.Defect depth
7.Defect angle
|
1.Early healing Index(HI) (Wachtel et al.2003)-after 1 week
2.Probing pocket depth (PPD) using UNC 15 probe-at baseline, 3months and 6 months
3.Clinical attachment loss(CAL)-at baseline, 3months and 6 months
4.Linear amount of bone fill-At baseline and 6 months
5.Percentage bone fill-at baseline and 6 months
6.Defect depth-at baseline and 6 months
7.Defect angle-at baseline and 6 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Plaque index (Silness and Loe,1964)
2.Gingival index(Loe and Silness 1963)
|
1.Plaque index (Silness and Loe,1964)- at baseline, 3months and 6 months
2.Gingival index(Silness and Loe,1964)-at baseline, 3months and 6 months
|
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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)
|
17/04/2025 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Patients reporting to the Department of Periodontics and Implantology, Vishnu Dental College with stage-II and III Grade- B and C Periodontitis as per 2017 classification will be included in the study and they will be randomly assigned to either of the groups. A written informed consent will be obtained from all the patients. Phlebotomy will be perfomed to collect blood of 10 ml to prepare T-PRF.After performing access flap surgery, the site is irradiated with Photobiomodulation followed by placement of T-PRF and suturing will be done. Post operatively the site is again irradiated with PBM in test group patients.In control group following access flap surgery T-PRF is placed and suturing will be done. Healing Index will be assessed after 1week. Clinical Parameters like Probing Depth, Clinical attachment level, Gingival Index, Plaque Index will be assessed at baseline, 3 months and 6 months. Radiological Parameters like Linear amount of bone fill, Percentage bone fill, Depth defect, Defect Angle will be assessed at Baseline and 6 months |