| CTRI Number |
CTRI/2023/07/055045 [Registered on: 11/07/2023] Trial Registered Prospectively |
| Last Modified On: |
24/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
A Clinical Study To Check Effects Of Laser On Jaw Bone Regeneration In Cases Of Pyorrhea. |
|
Scientific Title of Study
|
Clinico-radiographic evaluation of low-level laser therapy(lllt) for the treatment of horizontal bone defect – A randomized clinical study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Netra Alpesh Shah |
| Designation |
Post Graduate Student |
| Affiliation |
K.M.Shah Dental College and Hospital |
| Address |
Room no 7, Dept. Of Periodontology,K.M.Shah dental College And Hospital, Sumandeep Vidyapeeth Campus, Pipariya, Waghodia, Dist. Vadodara, Gujarat. 391760
Vadodara
GUJARAT
391760
India |
| Phone |
7874034141 |
| Fax |
|
| Email |
netrashah001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jasuma Rai |
| Designation |
Professor |
| Affiliation |
K.M.Shah Dental College And Hospital |
| Address |
Room no 7, Dept. Of Periodontology,K.M.Shah dental College And Hospital, Sumandeep Vidyapeeth Campus, Pipariya, Waghodia, Dist. Vadodara, Gujarat. 391760
Vadodara
GUJARAT
391760
India |
| Phone |
9974005760 |
| Fax |
|
| Email |
drjasumaj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jasuma Rai |
| Designation |
Professor |
| Affiliation |
K.M.Shah Dental College And Hospital |
| Address |
Room no 7, Dept. Of Periodontology,K.M.Shah dental College And Hospital, Sumandeep Vidyapeeth Campus, Pipariya, Waghodia, Dist. Vadodara, Gujarat. 391760
Vadodara
GUJARAT
391760
India |
| Phone |
9974005760 |
| Fax |
|
| Email |
drjasumaj@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room no 7, Dept. Of Periodontology,K.M.Shah Dental College and Hospital, Sumandeep Vidyapeeth Campus, Pipariya, Waghodia, Dist. Vadodara, Gujarat. 391760 |
|
|
Primary Sponsor
|
| Name |
Dr Netra Alpesh Shah |
| Address |
Room no 7, Dept. Of Periodontology,K.M.Shah Dental College and Hospital, Sumandeep Vidyapeeth Campus, Pipariya, Waghodia, Dist. Vadodara, Gujarat. 391760 |
| 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 Netra Alpesh Shah |
K.M Shah Dental College And Hospital |
Room NO.7, Department Of Periodontology, K.M.Shah Dental College and Hospital, Sumandeep Vidyapeeth, Pipariya, Waghodia, Vadodara,391760
Vadodara
GUJARAT |
7874034141
netrashah001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sumandeep Vidyapeeth Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Periodontitis Stage II and Stage III |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Simplified Papilla Preservation Technique with Intramarrow Penetration And Low level laser therapy with sticky bone |
LLLT is known as Cool lasing; they do not cut or ablate tissue. It has been demonstrated that mesenchymal stem cell proliferation and growth factor overexpression are improved by cold lasing, which is important for periodontal regeneration. It is a light-source treatment that improves the ability of the periodontal osseous defect to regenerate. Low level laser treatment will be given over bone defect for 60 seconds in non contact mode. Laser will be applied over bone for 20 seconds for 3 times with 10 seconds of interval between each application. |
| Comparator Agent |
Simplified Papilla Preservation Technique with Intramarrow Penetration And sticky bone |
LLLT is not used |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Systemically healthy Participants diagnosed with localized or generalized Stage II and III periodontitis within the age group of 30 to 60 years.
2 Participants with at least three nonadjacent sites with 5 to 7 mm of probing pocket depth and 3 to 4 mm of clinical attachment level with no contraindication to periodontal therapy.
3 Patients with a full-mouth plaque score and a full mouth bleeding score of less then 20 percentage after phase I therapy.
4 Patients showing horizontal bone loss in IOPA of chief complain site
|
|
| ExclusionCriteria |
| Details |
1 Patients requiring antibiotic prophylaxis before the periodontal examination.
2 Patients diagnosed with malocclusion at the site of the defect.
3 Patients with systemic disease and or on drugs that contraindicate periodontal surgery.
4 Pregnant and Lactating women
5 Participant with habit of smoking bidi or cigarettes, chewing tobacco or betel nut and has poor oral hygiene.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Plaque Index, Modified Gingival Index |
Baseline, 6 months, 9 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Probing Depth, Clinical Attachment Level, Radiographic defect depth, Defect fill Percentage |
Baseline, 6 months, 9 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
|
N/A |
|
Date of First Enrollment (India)
|
20/07/2023 |
| 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="1" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Other (Terminated) |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Low-Level Laser Therapy is known for faster healing procedure and regeneration of osseous defects by working on cellular level. Intramarrow penetration is a newer modality which shows regenerative effects on bone by enhancing blood supply to the bone graft and promoting progenitor cell activity. Simplified Papilla Preservation Flap (SPPF) technique is widely used as an alternative to open flap debridement technique and sticky bone is known for it’s regenerative efficacy. Horizontal Alveolar Bone Loss has prevalence of 97% in patients with in periodontitis , while treatment modality available are 3%. That’s why this type of alveolar defect is selected to increase the number of successful treatment modalities for it. |