| CTRI Number |
CTRI/2025/07/091007 [Registered on: 16/07/2025] Trial Registered Prospectively |
| Last Modified On: |
13/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Use of blood products in addition to erbium laser therapy in the treatment of reduced gums |
|
Scientific Title of Study
|
Adjunctive use of iPRF with or without Erbium Root Biomodification in the management of gingival recession coverage using a coronally
advanced flap A randomized controlled 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 |
Thamaraiselvan Murugan |
| Designation |
Professor |
| Affiliation |
Saveetha Dental College and Hospitals, Saveetha Institute of Medical and Technical Sciences |
| Address |
Department of Periodontics Saveetha Dental College and Hospitals 162 Velappanchavadi Poonamallee High Road Chennai Tamilnadu India
Thiruvallur
TAMIL NADU
600077
India
Chennai
TAMIL NADU
600077
India |
| Phone |
9884276922 |
| Fax |
|
| Email |
Thamaraiselvanperiodontics@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Thamaraiselvan Murugan |
| Designation |
Professor |
| Affiliation |
Saveetha Dental College and Hospitals, Saveetha Institute of Medical and Technical Sciences |
| Address |
Department of Periodontics Saveetha Dental College and Hospitals 162 Velappanchavadi Poonamallee High Road Chennai Tamilnadu India
Thiruvallur
TAMIL NADU
600077
India
Chennai
TAMIL NADU
600077
India |
| Phone |
9884276922 |
| Fax |
|
| Email |
Thamaraiselvanperiodontics@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Thamaraiselvan Murugan |
| Designation |
Professor |
| Affiliation |
Saveetha Dental College and Hospitals, Saveetha Institute of Medical and Technical Sciences |
| Address |
Department of Periodontics Saveetha Dental College and Hospitals 162 Velappanchavadi Poonamallee High Road Chennai Tamilnadu India
Thiruvallur
TAMIL NADU
600077
India
Chennai
TAMIL NADU
600077
India |
| Phone |
9884276922 |
| Fax |
|
| Email |
Thamaraiselvanperiodontics@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Dental College and Hospitals 162, Poonamallee High Road, velappanchavadi, Chennai, Tamilnadu, India. PIN - 600077 |
|
|
Primary Sponsor
|
| Name |
Thamaraiselvan Murugan |
| Address |
Department of Periodontics Saveetha Dental College and Hospitals 162 Poonamallee High Road Velappanchavadi Chennai Tamilnadu India |
| Type of Sponsor |
Other [Self funding ] |
|
|
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 |
| Thamaraiselvan Murugan |
Saveetha Dental College |
Saveetha Dental College and Hospitals
Department of periodontics
Chennai
TAMIL NADU |
9884276922
Thamaraiselvanperiodontics@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Institutional Human Ethical Committee, Chennai |
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 |
Group 1 (CAF+Er Laser+iPRF)
|
Coronally advanced flap (CAF) with erbium laser root bio modification (Er Laser) and injectable Platelet rich fibrin (iPRF) with 0,1,3months and 6months follow-up. 1ml of iPRF and Erbium laser of 0.75W power,Non contact pulsed mode for 30 seconds |
| Comparator Agent |
Group 2 (CAF +Er laser) |
Coronally advanced flap (CAF) with erbium laser root biomodification (Er laser) with 0,1,3months and 6months follow-up. Erbium laser of 0.75W power,Non contact pulsed mode for 30 seconds |
| Comparator Agent |
Group 3 (CAF + iPRF ) |
Coronally advanced flap (CAF) with injectable Platelet rich fibrin (iPRF) with 0,1,3months and 6months follow-up. 1ml of iPRF |
| Comparator Agent |
Group 4 (CAF) |
Coronally advanced flap (CAF) with 0,1,3months and 6months follow-up
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Miller class 1 recession / RTI 1
width of keratinised gingiva greater than or equal to 2mm apical to gingival margin
Probing Depth(PD) lesser than or equal to 3mm .
|
|
| ExclusionCriteria |
| Details |
1.patients with systemic disease
2.patient under medications that contraindicate periodontal surgery
3.smokers
4.pregnant or lactating mothers
5.recession defects with caries or non carious lesions with or without pulpal pathology
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Mean Recession Coverage (MRC)
Complete Recession Coverage (CRC)
|
Baseline
1 month
3 month
6 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Width of Keratinised Gingiva (WKG)
Healing Index (HI)
Probing Depth(PD)
Clinical Attachment Loss (CAL)
Visual Analog Score (VAS)
Recession Depth (RD)
Recession Width (RW) |
Baseline
1 month
3 month
6 month |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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 2 |
|
Date of First Enrollment (India)
|
12/08/2025 |
| 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="0"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
Gingival Recession is the apical migration of marginal gingiva as well as the fact that the latter is gradually displaced away from the cementoenamel junction, thereby exposing the root surface to the oral environment. Treatment options for this condition include coronally advanced flap technique and the lateral pedicle flap procedure,free gingival grafts etc which aim to restore the gingival tissue. While healing occurs with the formation of a long junctional epithelium (JE), the risk of recurrence remains high. Efforts to facilitate true regeneration of the gingival tissue are ongoing. One such approach is root biomodification, which involves exposing the root collagen proteins to regenerating cells to promote true regeneration of epithelium and facilitate healing. This is typically done with agents like citric acid,enamel matrix proteins and fibronectin etc though no agent has yet been identified as ideal or fully satisfactory.For successful regeneration, it is essential to have an intact fibrin attachment, which is critical for enabling true attachment of the periodontal tissue to the root surface. In Erbium-laser root biomodification, the use of the erbium laser facilitates the modification of the root surface, making it more conducive for fibroblast attachment, which is essential for periodontal healing. This technique enhances the root surface, improving its ability to support the attachment of regenerating cells, specifically fibroblasts, which play a crucial role in tissue repair and regeneration.When combined with iPRF (Injectable Platelet-Rich Fibrin), a form of platelet-rich fibrin derived from the patient’s own blood, this treatment approach may show enhanced outcomes. iPRF may provides fibrin that support tissue healing and regeneration, stimulating fibroblast activity and accelerating the repair of periodontal tissues. The CAF technique can effective soft tissue coverage, while Erbium-laser root biomodification may optimise the root surface for fibroblast attachment and may promotes tissue regeneration.Together, these three treatment modalities may create a synergistic effect that supports more effective periodontal regeneration, reduces inflammation, and facilitates true attachment to the root surface. |