| CTRI Number |
CTRI/2026/01/100635 [Registered on: 09/01/2026] Trial Registered Prospectively |
| Last Modified On: |
09/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of Modified Vestibular Incision Subperiosteal Tunnel Technique and Advanced Platelet Rich Fibrin Plus with Low Level Laser Therapy in the treatment of receding gums |
|
Scientific Title of Study
|
Comparison of Modified Vestibular Incision Subperiosteal Tunnel Technique (MVISTA) with Advanced Platelet Rich Fibrin Plus (A-PRF+) with and without use of adjunctive Low Level Laser Therapy (LLLT) in management of Cairo’s RT1 gingival recessions: A Randomized 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 |
Dr Ankita Chakraborty |
| Designation |
Postgraduate |
| Affiliation |
Manipal College Of Dental Sciences Mangalore |
| Address |
Department Of Periodontology 4th Floor Manipal
College Of Dental Sciences Mangalore Affiliated To
Manipal Academy Of Higher Education, Manipal
Karnataka
Dakshina Kannada
Karnataka
575001
India
Dakshina Kannada KARNATAKA 575001 India |
| Phone |
9430993537 |
| Fax |
|
| Email |
chakrabortyank99@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Deepa G Kamath |
| Designation |
PROFESSOR |
| Affiliation |
Department Manipal College Of Dental Sciences Mangalore |
| Address |
Department Of Periodontology 4th Floor Manipal
College Of Dental Sciences Mangalore Affiliated To
Manipal Academy Of Higher Education, Manipal
Karnataka
Dakshina Kannada
Karnataka
575001
India
Dakshina Kannada KARNATAKA 575001 India |
| Phone |
9448454788 |
| Fax |
|
| Email |
deepa.gkamath@manipal.edu |
|
Details of Contact Person Public Query
|
| Name |
Dr Deepa G Kamath |
| Designation |
Professor |
| Affiliation |
Manipal College Of Dental Sciences Mangalore |
| Address |
Department Of Periodontology 4th Floor Manipal
College Of Dental Sciences Mangalore Affiliated To
Manipal Academy Of Higher Education, Manipal
Karnataka
Dakshina Kannada
Karnataka
575001
India
Dakshina Kannada KARNATAKA 575001 India |
| Phone |
9448454788 |
| Fax |
|
| Email |
deepa.gkamath@manipal.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Ankita Chakraborty |
| Address |
Department Of Periodontology 4th Floor Manipal
College Of Dental Sciences Mangalore Affiliated To
Manipal Academy Of Higher Education, Manipal
Karnataka
Dakshina Kannada
Karnataka
575001
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 Ankita Chakraborty |
Depar Manipal College Of Dental Sciences Mangalore |
Department Of Periodontology 4th Floor Manipal
College Of Dental Sciences Mangalore Affiliated To
Manipal Academy Of Higher Education, Manipal
Karnataka
Dakshina Kannada
Karnataka
575001
India
Dakshina Kannada KARNATAKA |
9430993537
chakrabortyank99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Manipal College of Dental Sciences, Mangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Systemically healthy patients |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Modified Vestibular Incision Sub-Periosteal Tunnel Access with Advanced Platelet-rich Fibrin Plus |
To compare the clinical efficacy of Modified Vestibular Incision SubPeriosteal Tunnel Access with Advanced Platelet-rich Fibrin Plus followed by Low Level Laser Therapy,and Modified Vestibular Incision Sub-Periosteal Tunnel Access with Advanced Platelet-rich Fibrin Plus in the management of Cairo’s RT1 gingival recessions with 6 months follow up
|
| Intervention |
To compare the clinical efficacy of Modified Vestibular Incision Sub-Periosteal Tunnel Access with Advanced Platelet-rich Fibrin Plus followed by Low Level Laser Therapy |
To compare the clinical efficacy of Modified Vestibular Incision SubPeriosteal Tunnel Access with Advanced Platelet-rich Fibrin Plus followed by Low Level Laser Therapy,and Modified Vestibular Incision Sub-Periosteal Tunnel Access with Advanced Platelet-rich Fibrin Plus in the management of Cairo’s RT1 gingival recessions with 6 months follow up
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients who agree to participate in the study by signing the informed consent
Presence of more than or equal to 2mm adjacent Cairo’s RT1 gingival recessions on aesthetic zones including premolars in the maxillary or mandibular arch with an apico-coronal extension
Probing depth less than 3 mm
Full mouth plaque index score less than 20 percent
Gingival thickness more than or equal to 2mm
|
|
| ExclusionCriteria |
| Details |
Patients with systemically compromised health
Previous periodontal surgical treatment in the involved site
Pregnant or lactating mothers
Patient with smoking habit
Non compliant patients
Restorations and superficial caries in the area to be treated
Mobile or fully restored teeth
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Recession depth
Recession width
Probing depth
Clinical attachment level
Keratinized tissue height
Gingival thickness
Mean Root Coverage
Complete Root Coverage
|
Baseline
1 month
3 month
6 month
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Early Wound Healing Scores |
24 hours postoperative |
| Root Coverage Esthetic Score |
6 month postoperative |
| Plaque index |
baseline
6 month |
| Modified sulcular bleeding index |
baseline
6 months |
| Patient Reported Outcome Measures |
3 months
6 months |
|
|
Target Sample Size
|
Total Sample Size="16" Sample Size from India="16"
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)
|
03/04/2026 |
| 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="2" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 defined as the displacement of the marginal tissue apical to the
cementoenamel junction resulting in exposure of the root surface and
potentially creating aesthetic and functional problems such as dentine
hypersensitivity and root caries It affects populations worldwide, occurring across
all age groups with multiple etiological factors contributing to its
development, and prevalence is seen to increase with age Common etiological factors are inadequate oral
hygiene faulty toothbrushing, smoking or chewing tobacco and malocclusion among others The
classification of gingival recession has evolved significantly over time aimed
at improving diagnosis prognosis and treatment planning The earliest
classification by Sullivan and Atkins in 1968 categorized recessions based on
the depth and width of the defect into four types deep wide shallow wide deep narrow and shallow narrow This was followed by Miller classification
in 1985 which became the most widely used system Miller divided recessions
into four classes based on the extent of recession relative to the mucogingival
junction and the presence or absence of interdental bone and soft tissue However Miller classification of gingival recession has several drawbacks including difficulty
locating the MGJ lack of information on keratinized tissue vague criteria for
interdental bone loss and inability to classify palatal recessions or cases
where interdental bone loss occurs without recession extending beyond the MGJ.
Moreover, its prognostic predictions are often inaccurate, as clinical outcomes
do not always conform to Miller’s expectations for root coverage. To address
these shortcomings, newer classifications were introduced. For example, in
1998, Nordland and Tarnow proposed a classification based on the height of
interdental papillae. The Cairo classification, introduced in 2011, utilized
interproximal clinical attachment level as a more objective and
reproducible criterion. The Cairo system categorizes recessions into three
types depending on the severity of interproximal attachment
loss relative to buccal attachment loss. RT1 Gingival recession with no loss
of interproximal attachment. Interproximal CEJ was clinically not Detectable at
both mesial and distal aspects of the tooth. RT2: Gingival recession associated
with loss of interproximal attachment. The amount of interproximal attachment
Loss was less than or equal to the Buccal attachment loss RT3: Gingival recession
associated with loss of interproximal attachment. The amount of interproximal
attachment Loss was Higher than the buccal attachment loss. This allows a
clearer distinction among recession types and more accurate prediction of root
coverage outcomes. Studies have shown that Cairo classification is more
reliable, with higher intra- and inter-examiner agreement than Miller’s, and
offers a clearer, treatment-oriented approach by focusing on attachment loss
rather than the variable MGJ This makes the
Cairo classification more practical and precise for diagnosis, prognosis, and
treatment planning in periodontology. Other contemporary modifications and new
systems incorporate details such as keratinized tissue, tooth malposition, and
palatal recessions to provide a more comprehensive clinical picture.The primary objectives of treating
gingival recession are to achieve root coverage, restore esthetics, facilitate
plaque control and reduce hypersensitivity Tunnel techniques represent a minimally invasive
surgical approach to treat multiple gingival recessions by creating a
subperiosteal tunnel through a single incision, allowing graft placement
without disrupting the blood supply to the flap. The absence of vertical
incisions and papilla detachment provides better blood supply, promotes
post-operative healing and reduces
visible scarringThe Vestibular Incision Subperiosteal Tunnel Access technique is an advancement in tunnel procedures. It utilises a
vestibular incision to enhance flap mobilization, thus covering multiple
recession defects with minimal trauma The Modified Vestibular Incision Subperiosteal Tunnel
Access technique differs from the VISTA technique mainly with respect
to incision design, the supra-periosteal tunnel, graft material used and the
method of suturing. In MVISTA, a single vestibular incision is used to
establish a wider mucoperiosteal tunnel for complete elevation and passage of
grafts, thus reducing trauma and increasing flap mobility These modifications enhance access, facilitate multiple
root coverage at once, and have been seen to achieve more predictable and
stable long term clinical results in gingival recession treatment. Platelet-Rich
Fibrin is a second-generation autologous platelet concentrate platelet rich fibrin is
simple to prepare and affordable since it requires no additional activation
factors or anticoagulants. Its fibrous structure forms a three-dimensional
fibrin scaffold that retains more cytokines and growth factors, releasing them
gradually over 10 days, creating a natural, sustained healing environment.
Additionally platelet rich fibrin dissolves more slowly in tissue, forming a solid fibrin
matrix resembling a natural blood clot, for better tissue integration.Thus .platelet rich fibrin promotes tissue healing and regeneration, and
when combined with Vestibular Incision Subperiosteal Tunnel Access technique improves biotype and healing of tissue and covers
multiple recession areas well Third generation PRF Advanced
Platelet-Rich Fibrin Plus offers superior healing and regenerative
benefits over earlier platelet rich fibrin generations, mainly due to its enhanced release of
growth factors achieved by slower and shorter centrifugation processes. Studies
consistently show that Advanced Platelet-Rich Fibrin Plus improves bone formation supports gingival and
periodontal healing, and enhances outcomes in bone graft integration and ridge
preservation when compared with both conventional platelet rich fibrin and other blood-derived
biomaterials. The increased concentration of key growth factors and cytokines
in A-PRF+ results in faster neoangiogenesis, more efficient cellular responses,
and better maintenance of tissue dimensions at surgical sites, making it a
preferred adjunct in contemporary periodontal and oral surgical procedures. Advanced
Platelet-Rich Fibrin Plus demonstrates superior clinical performance
compared to earlier platelet rich fibrin generations, primarily due to increased release of
growth factors and cytokines that promote tissue healing and regeneration, with
studies showing improved bone formation, better graft integration, and enhanced
periodontal outcomes in various surgical protocols. Photobiomodulation refers to the
therapeutic use of low-level laser light to stimulate cellular activity and
enhance tissue repair without causing thermal damage. Low-Level Laser Therapy is a form of photobiomodulation applied in periodontal treatment to
reduce inflammation, pain, and promote wound healing, often used adjunctively
with surgical techniques to improve clinical results.
Low level laser therapy supports post-surgical healing by employing
low-intensity laser light to stimulate cellular processes at the wound site,
enhancing tissue repair and regeneration without causing thermal damageLow-Level Laser Therapy accelerates healing by promoting mitochondrial activity and ATP production,
which boosts cellular energy and facilitates fibroblast proliferation,
angiogenesis, and collagen synthesis essential for soft tissue recovery after
surgery. Low-level laser therapy sterilizes tissue surfaces, modulating inflammatory response and reducing the
risk of bacteremia and minimizing swelling, edema, and scarring by
decreasing inflammatory cytokines, improving lymphatic drainage, and lowering
vascular permeability ClinicallyLow-Level Laser Therapy has been shown to significantly decrease postoperative pain and the consumption
of analgesics, optimize tissue repair, and promote wound closure, giving it a
valuable adjunctive role in the post-surgical management of gingival recessions
and periodontal procedures |