| CTRI Number |
CTRI/2024/10/075713 [Registered on: 23/10/2024] Trial Registered Prospectively |
| Last Modified On: |
13/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Preventive
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to evaluate laser and blood concentrate to increase oral sulcus and gum height.
(oral sulcus-space between buccal mucosa and gums) |
|
Scientific Title of Study
|
Comparison of low level laser therapy in conjunction with diode laser & I-PRF with microneedling assisted vestibuloplasty for keratinised layer differentiation & vestibular depth gain - A Randomised clinical trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrVikas Gopalghare |
| Designation |
Post graduate student |
| Affiliation |
Jawahar Medical Foundations Annasaheb Chudaman Patil Memorial Dental college,Dhule |
| Address |
Department of periodontology,
Room No3,
Annasaheb Chudaman Patil Memorial Dental college,
Sakri road,Dhule,
tal.Dist.-Dhule,
Affiliated to MUHS Nashik.
Dhule
MAHARASHTRA
424001
India |
| Phone |
9096120974 |
| Fax |
02562279924 |
| Email |
vikasgopalghare748@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lalitha Shiggaon |
| Designation |
Professor |
| Affiliation |
Jawahar Medical Foundations Annasaheb Chudaman Patil Memorial Dental college,Dhule |
| Address |
Department of Periodontology,
room no. 3,
Annasaheb Chudaman Patil Memorial Dental College,
Sakri road,Dhule
tal.dist.-Dhule
Affiliated to MUHS Nashik.
Dhule
MAHARASHTRA
424001
India |
| Phone |
8408876666 |
| Fax |
02562279924 |
| Email |
drlalithavk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Lalitha Shiggaon |
| Designation |
Professor |
| Affiliation |
Jawahar Medical Foundations Annasaheb Chudaman Patil Memorial Dental college,Dhule |
| Address |
Department of Periodontology,
room no. 3,
Annasaheb Chudaman Patil Memorial Dental College,
Sakri road,Dhule
tal.dist.-Dhule
Affiliated to MUHS Nashik.
Dhule
MAHARASHTRA
424001
India |
| Phone |
8408876666 |
| Fax |
02562279924 |
| Email |
drlalithavk@gmail.com |
|
|
Source of Monetary or Material Support
|
| Annasaheb Chudaman Patil Memorial Dental college,
Department of periodontology,
Room No3,
Sakri road,Dhule,
tal.Dist.-Dhule,
pin-424001.
country-Maharashtra. |
|
|
Primary Sponsor
|
| Name |
DrVikas Gopalghare |
| Address |
room no 3
Department of periodontology And oral Implantology,
Annasaheb Chudman Patil Memorial Dental College,
Sakri road,Dhule,
pin 424001. |
| 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 |
| DrVikas Gopalghare |
Jawahar Medical Foundations Annasaheb Chudaman Patil Memorial Dental College |
Room no 3,
Department of Periodontology and Oral Implantology,
Annasaheb Chudaman Patil Memorial Dental College,Dhule
Post Box no 145,
Sakri Road,
Dhule.
Dhule
MAHARASHTRA |
02562277924
0256227994
vikasgopalghare748@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
DIODE LASER VESTIBULOPLASTY+ DIODE LASER BIOSTIMULATION |
1)FIRST VISIT
After consent form, case history will be recorded. Photographs will be taken and all the parameters of the study will be recorded.
Scaling and root planning will be performed and all the patients will be advised to follow good oral hygiene.
2)SECOND VISIT-
DIODE LASER VESTIBULOPLASTY:
After application of topical anesthetic, agent and adequate anesthesia will be attained with a local infiltration, a 980 nm wavelength diode laser will be used with the following settings-
Power 1W-1.6W in a continuous mode.
Ablation with the laser tip was initiated at the mucogingival junction with a horizontal stroke directing the laser parallel to the bone slowly reliving the muscle fibers till the desired depth.
DIODE LASER BIOSTIMULATION-
Considering the vast wound area post vestibuloplasty procedure, diode laser biostimulation will be used to enhance the wound healing by using a special diode laser biostimulation handpiece.
The handpiece will be used in the biostimulation mode with a power setting of 1-1.6W starting at a distance of 6-8 mm away from the wound area and slowly approaching within a distance of 2-3 mm in a scanning motion covering the entire wound bed for a period of 30-50 sec.
3)THIRD AND FOURTH VISITS-
(Diode laser biostimulation will be performed in 3 visits starting immediate postoperatively and on the every 2 days after the diode laser vestibuloplasty) |
| Intervention |
MICRONEEDLING + I-PRF INJECTION +DIODE LASER BIOSTIMULATION |
1)FIRST VISIT-
After consent form, case history will be recorded. Photographs will be taken and all the parameters of the study will be recorded.
Scaling and root planning will be performed and all the patients will be advised to follow good oral hygiene.
2)SECOND VISIT-
Application of topical anesthetic gel at the site.
Microneedling will be performed in the vestibule using Microneedling pen.
After the Microneedling, diode laser biostimulation will be performed at a power setting of 1W-1.6 W and exposure time of 30-50 sec.
Patient will be advised to follow good oral hygiene.
3)THIRD VISIT-
48 hours after the 2nd visit, patient will be recalled for diode laser biostimulation (Power 1-1.6 W , exposure time of 30-50 sec).
4)FOURTH VISIT-
48 hours after the 3rd visit, patient will be recalled for diode laser biostimulation (Power 1-1.6 W , exposure time of 30-50 sec).
This completes the intervention of the diode laser biostimulation.
5)FIFTH VISIT-
Patient will be recalled 10 days after the baseline for I-PRF injections.
PREPERATION OF I-PRF
A 5ml injection will be used on each patient to take blood from a vein. It will be centrifuge for 3 min at room temperature at 700 RPM after being divided into 10ml I-PRF tubes with no anticoagulant.
I-PRF so prepared will be transformed into the 1 ml microneedle syringe (30G×8mm needle insulin syringe)
Application of topical anesthetic gel at the site.
After acquiring adequate topical anesthesia I-PRF injection will be injected at a site where there is inadequate vestibular depth.
Post operative instructions will be given and patient will be recalled after every 10 days.
(The next 2 appointments will be scheduled for I-PRF injections 10 days after the 5th and 6th appointment respectively). |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Male or female above 16 years of age.
2.Patient with inadequate vestibular depth.
3.Patient with narrow keratinized gingiva.
4.Single or multiple gingival recession.
5.Abberant frenal attachment. |
|
| ExclusionCriteria |
| Details |
1.Medically compromised patient.
2.Patient not willing to participate in the study. |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare and evaluate the vestibular depth and width of keratinised gingiva, keratinized tissue thickness after injecting I-PRF following Microneedling and Laser Vestibuloplasty using Laser Biostimulation. |
vestibular depth & width of keratinised gingiva, thickness of keratinized tissue- time point baseline, 3 months & 6 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Gingival recession depth, clinical attachment loss, probing pocket depth are the secondary outcomes. |
Gingival recession depth, clinical attachment loss, probing pocket depth - time points baseline, 3 months, 6 months. |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
16/11/2024 |
| 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="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [vikasgopalghare748@gmail.com].
- For how long will this data be available start date provided 05-09-2024 and end date provided 05-02-2027?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This is double-blind randomized clinical trial, Which compares the effects of low level laser therapy in conjunction with diode laser and microneedling with I-PRF injection assisted vestibuloplasty for keratinized layer differentiation and vestibular depth gain. The study evaluates primary hypothesis as Are there any changes in vestibular depth and width of keratinized gingiva using two different methods in patient having inadequate vestibular depth. The primary outcome measures will be increase in vestibular depth, keratinized tissue width and keratinized tissue thickness. Recession depth, clinical attachment loss, probing pocket depth are the secondary outcome will be measured at baseline , 3 months, and 6 months. |