| CTRI Number |
CTRI/2024/08/072144 [Registered on: 08/08/2024] Trial Registered Prospectively |
| Last Modified On: |
01/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical study comparing Hemolasertherapy and I-PRF for the treatment of Black triangle |
|
Scientific Title of Study
|
Comparative evaluation of the Efficacy of Injectable Platelet rich fibrin and Hemolaser Therapy in Interdental papilla Reconstruction A 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 |
Deepikashree K |
| Designation |
Postgraduate |
| Affiliation |
Adhiparasakthi Dental College and Hospital |
| Address |
Department of Periodontics and Implantology
Room number 5
Adhiparasakthi Dental College and Hospital
GST Road
Melmaruvathur
Chengalpattu Dt
Kancheepuram
TAMIL NADU
603319
India |
| Phone |
7010384369 |
| Fax |
|
| Email |
deepshree99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Magesh Kumar S |
| Designation |
Professor and Head |
| Affiliation |
Adhiparasakthi Dental College and Hospital |
| Address |
Department of Periodontics and Implantology
Room number 5
Adhiparasakthi Dental College and Hospital
GST Road
Melmaruvathur
Chengalpattu Dt
Kancheepuram
TAMIL NADU
603319
India |
| Phone |
7060027511 |
| Fax |
|
| Email |
drmagesh76@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Deepikashree K |
| Designation |
Postgraduate |
| Affiliation |
Adhiparasakthi Dental College and Hospital |
| Address |
Department of Periodontics and Implantology
Room number 5
Adhiparasakthi Dental College and Hospital
GST Road
Melmaruvathur
Chengalpattu Dt
Kancheepuram
TAMIL NADU
603319
India |
| Phone |
7010384369 |
| Fax |
|
| Email |
deepshree99@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Periodontics and Implantology
Room number 5
Adhiparasakthi Dental College and Hospital
GST Road
Melmaruvathur 603319
Chengalpattu Dt
Tamilnadu
India |
|
|
Primary Sponsor
|
| Name |
Deepikashree K |
| Address |
Department of Periodontics and Implantology
Room number 5
Adhiparasakthi Dental College and Hospital
GST Road
Melmaruvathur 603319
Chengalpattu Dt
Tamilnadu
India |
| 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 Deepikashree |
Adhiparasakthi Dental College and Hospital |
Department of Periodontics and Implantology
Room number 5
Adhiparasakthi Dental College and Hospital
GST Road
Melmaruvathur
Kancheepuram
TAMIL NADU |
7010384369
deepshree99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Adhiparasakthi Dental College and Hospital Melmaruvathur 603319 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K056||Periodontal disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hemolasertherapy (HLT) |
Hemolasertherapy (HLT) is a nonsurgical treatment modality based on Photo Biomodulation of mesenchymal cells within the blood. Frequency is Once (At baseline) Duration of intervention is Once (At baseline ) follow up at 1month 3month and 6 month |
| Comparator Agent |
Injectable Platelet Rich Fibrin (iPRF) |
Platelet Rich Fibrin, particularly its injectable form known as Injectable platelet-rich fibrin (iPRF), has gained widespread usage in various periodontal regenerative procedures including papilla reconstruction. Frequency is Once (At baseline) Duration of intervention is Once (At baseline ) follow up at 1month 3month and 6 month |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subjects exhibiting a healthy periodontium aside from deficient papilla as determined by score 2 of Cardaropoli Papilla Presence Index
Presence of good oral hygiene maintenance
Systemically healthy patients
Non smoker
|
|
| ExclusionCriteria |
| Details |
Immunocompromised patients
Pregnant and lactating women
Patients who have undergone periodontal surgery in same area within last 6 months
Patients under any medication known to affect the periodontium
Patients with bruxism
Patients exhibiting parafunctional habits and traumatic occlusion
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Papillary Regeneration |
1 month 3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The secondary outcomes will be an improvement in
Plaque Index
Gingival Index
Gingival thickness |
12 TO 18 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
01/11/2024 |
| 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="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
|
1. All the subjects who fulfilled the eligibility criteria will be educated and motivated for the treatment. Written Informed consent will be obtained from all the patients who shows their willingness for participation in the study. Following this, the subjects will undergo supragingival and subgingival Professional Mechanical Plaque removal (PMPR) with ultrasonic scalers and hand instrumentation completed 3 -4 weeks prior to the procedure. 2.Pre-procedural preparation; Stent Preparation; Individually fabricated occlusal/incisal stents will be made for standardization of the measurement. These stents will cover the incisal surface in the mesial and distal directions, extending to the teeth to cover the incisal and mid-coronal third of labial and lingual surfaces. A groove will be incorporated into the interdental part of the stent on the labial aspect to ensure the placement of the probe parallel to the tooth surface to measure the tip from a reference point on the stent. 3.Phenotype determination: The estimation of keratinized tissue width is done by using a UNC-15 probe attached with an endodontic rubber stopper. The upper lip will be stretched to determine the mucogingival Junction & Then the UNC-15 probe will be placed to measure the keratinized tissue width (KTW) from Mucogingival junction to the marginal gingiva. Gingival thickness will be assessed mid buccally halfway between the mucogingival junction and marginal gingiva using an endodontic spreader fitted with a rubber stopper and measured on the probe. 4.Following the phase I periodontal therapy, the clinical parameters will be recorded & clinical photographs will be taken prior to the procedure. 5.I-PRF Preparation I-PRF will be prepared as per the protocol by Miron et al (2017). 10ml of intravenous blood will be drawn from the patient and transferred to plastic non-coated test tubes. The blood then be immediately centrifuged at 700rpm for 3 minutes. The i-PRF will be withdrawn in an insulin syringe and used. 6.Procedure for injecting I-PRF After administration of Local anesthesia (1:80,000) at the treatment site, the insulin syringe filled with I-PRF will be inserted at a 45° angle ensuring the bevel was up by pointing the slant of the needle upward. I-PRF will be injected 2–3 mm apical to the tip of the papilla before the liquid turns into a gel consistency. 7.Hemolasertherapy After the application of topical anesthetic agent, Points will be marked on the gingiva with a tissue marker. Three points per tooth, and one point between the labial and lingual papilla. PBMT will be applied with a diode laser in two stages: •The first PMBT will be applied before bleeding to stimulate local microcirculation. •The second PMBT will be applied immediately after bleeding to stimulate stem cells. Each spot will be irradiated with 660nm diode laser at a power setting of 100 mW for 20 seconds/ maximum energy of 2J per point 8. Pricks will be made on the gingiva with explorer tip on every bleeding point marked. The blood will be allowed to flow into the sulcus and the interdental embrasure. The bleeding spots will be then irradiated with the same power setting. 9.The follow-ups will be conducted at 1 month, 3 months & 6 months post treatment to assess the sustainability of the esthetic results. •The primary outcome will be Papillary Regeneration •The secondary outcomes will be an improvement in a.Plaque Index b.Gingival Index c.Gingival thickness |