CTRI Number |
CTRI/2023/11/059413 [Registered on: 02/11/2023] Trial Registered Prospectively |
Last Modified On: |
09/11/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Dentistry |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
A Comparative Analysis of Clinical Outcomes in Gingival Recession Treatment: VISTA Technique Alone Versus VISTA Technique Combined with Platelet-Rich Fibrin (PRF)
|
Scientific Title of Study
|
Comparative evaluation of Vestibular Incision Subperiosteal Tunnel access(VISTA) technique alone and in combination with platelet rich fibrin(PRF) for the treatment of multiple gingival recessions |
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 Anagha Gawai |
Designation |
Post Graduate Student |
Affiliation |
SMBT Dental college and Hospital |
Address |
G-02,Department of PEriodontics,SMBT Dental college and hospital. Sangamner Ahmadnagar MAHARASHTRA 422608 India |
Phone |
8767447740 |
Fax |
|
Email |
anagha.gawai@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Purushottam Rakhewal |
Designation |
Professor and Head of Department |
Affiliation |
SMBT Dental college and Hospital |
Address |
G-02,
Department of Periodontics,
SMBT Dental college and hospital. Sangamner Ahmadnagar MAHARASHTRA 422608 India |
Phone |
9370017343 |
Fax |
|
Email |
drpsrakhewar@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr. Purushottam Rakhewar |
Designation |
Head Of Department,Professor And PG Guide |
Affiliation |
SMBT DENTAL COLLEGE AND HOSPITAL |
Address |
G-02,Department of Periodontics, SMBT Dental college sangamner Ahmadnagar MAHARASHTRA 422608 India |
Phone |
9370017343 |
Fax |
|
Email |
drpsrakhewar@gmail.com |
|
Source of Monetary or Material Support
|
SMBT Dental college and Hospital,amrutnagar,sangamner-422608 |
|
Primary Sponsor
|
Name |
None |
Address |
None |
Type of Sponsor |
Other [None] |
|
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 Anagha Gawai |
SMBT Dental college and hospital |
G-02,Department of Periodontics
Ahmadnagar MAHARASHTRA |
8767447740
anagha.gawai@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Committee on Ethics, SMBT dental college and hospital,sangamner |
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 |
VISTA Technique |
Vestibular incision subperiosteal access tunnel technique will be performed to treat patients with millers class I multiple gingival recessions and will be recalled for follow up on 7th day 3 months and 6 months period |
Comparator Agent |
VISTA Technique with Prf |
Vestibular incision subperiosteal access tunnel technique will be performed along with placement of platelet rice fibrin plug to treat patients with millers class I multiple gingival recessions and will be recalled for follow up on 7th day 3 months and 6 months period |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
50.00 Year(s) |
Gender |
Both |
Details |
1)At least 2 recession- type defects affecting adjacent teeth with Class І or class ІІ miller’s recession defects.
2)Recession depths ≥ 1mm.
3)Probing depth < 3mm without bleeding on probing.
4)Presence of identifiable CEJ.
5)Patient willing to give written informed consent.
|
|
ExclusionCriteria |
Details |
1)General contraindications to surgery.
2)Individuals with unacceptable oral hygiene.
3)Patients with active periodontal disease or systemic diseases or pregnancy.
4)Patients taking medications or having treatment with an effect on mucosal healing.
5)Patient who participated in clinical trial within past 6 months.
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
Method of Concealment
|
Alternation |
Blinding/Masking
|
Investigator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Reduction of gingival marginal recession depth |
Baseline to 6 months |
|
Secondary Outcome
|
Outcome |
TimePoints |
NONE |
NONE
|
|
Target Sample Size
|
Total Sample Size="24" Sample Size from India="24"
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 4 |
Date of First Enrollment (India)
|
20/11/2023 |
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="0" 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- 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 [anagha.gawai@gmail.com].
- For how long will this data be available start date provided 01-10-2024 and end date provided 01-12-2024?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
Brief Summary
|
Aim of the study is to comparative evaluation of vestibular incision subperiosteal tunnel access(VISTA) technique alone and in combination with platelet rich fibrin(PRF) for the treatment of multiple gingival recessions. All the participants will be explained the need and design of the study. Informed and written consent will obtained from the patients. Thorough clinical case history will be recorded. Each patient will undergo ultrasonic scaling (ems) by a single operator. All clinical parameters (PI,BOP,RD,RW,CAL,KTG,RES,PD,PERCENTAGE ROOT COVERAGE) will be measured using UNC 15 periodontal probe(Hufriedy) at baseline, 3 months and 6 months and VAS will be recorded at 1st day, 10th day, 3 months and 6 months post surgically. It is a single blind study in which the patient will be randomly assigned to either VISTA (control group) or VISTA with PRF (test group) using manual lottery method. After allotment of the groups following surgical procedure will be performed. For control group (VISTA technique)- The procedure will be carried out under local anesthesia (lignocaine HCL with 2% epinephrine 1: 200,000). Disinfection of the surgical site will be done with 2% betadine. The vista approach will begin with the vestibular access incision below mucogingival junction and the location of the access incision will be mesially or distally depending on the sites being treated. The incision is made through periosteum to elevate a sub periosteal tunnel, exposing the facial osseous plate as well as root dehiscence. This tunnel will be extended at least one or two teeth beyond the teeth requiring root coverage to mobilize gingival margin and facilitate coronal repositioning. A microsurgical periosteal elevator (vista 4) is used to extend the subperiosteal tunnel. The vista elevator is introduced through the vestibular access incision and inserted between the periosteum and bone to elevate the periosteum, creating the subperiosteal tunnel. It is important to extend the tunnel elevation sufficiently beyond the mucogingival margin as well as through the gingival sulcus of the teeth being augmented to allow for low-tension coronal repositioning of the gingiva. Additionally, the subperiosteal tunnel is extended interproximally under each papilla as far as the embrasure space permitted, without making any surface incisions through the papillae. This subperiosteal tunnel is repositioned coronally and adapted passively to cej covering the recession defects. Coronally anchored sutures are placed engaging the 2–3 mm apical gingival margin of individual tooth using 4-0 silk suture. The suture is secured at the midcoronal point of the facial aspect of each tooth with the help of composite resin button to prevent apical relapse of the gingival margin. Once coronal stabilization and proper adaptation of the marginal gingiva is achieved then the vertical incision is sutured for the primary closure. Complete surgical site is covered with coe-pack. For test group (VISTA with PRF technique)- A) preparation of PRF - around 5 ml of whole venous blood is collected in each of the two sterile vacutainer tubes of 6 ml capacity without anticoagulant. The vacutainer tubes are then placed in a centrifugal machine at 3000 revolutions per minute (rpm) for 10 minutes, after which it settles into the following layers: red lower fraction containing red blood cells, upper straw colored cellular plasma and the middle fraction containing the fibrin clot. The upper straw colored layer is then removed and middle fraction is collected, 2 mm below lower dividing line, which is the prf. B) surgical procedure- the same surgical procedure will be carried out as seen in the control group. After the procedure while suturing, coronally anchored sutures will be placed engaging the 2–3 mm apical gingival margin of individual tooth using 4-0 silk suture. The suture is secured at the midcoronal point of the facial aspect of each tooth with the help of composite resin button to prevent apical relapse of the gingival margin. Once coronal stabilization is achieved, freshly prepared prf membrane is inserted through the tunnel using the small periosteal elevator and spread it uniformly on recession defects. After complete and proper adaptation of the membrane the vertical incision is sutured for the primary closure. Complete surgical site is covered with coe-pack. The following post-operative measures will be explained to the patients 1) suitable antibiotics (amoxicillin 500mg t.i.d. For 5 days), analgesic (diclofenac sodium 50 mg and paracetamol 500 mg t.i.d. For 5 days) will be prescribed, along with 0.2% chlorhexidine digluconate rinses 10 ml for 1 minute, twice daily for 2 weeks. 2)Sutures will be removed after 10 days postoperatively. 3)Patients will be instructed to avoid usage of toothbrush at surgical site. Teeth cleaning at surgical site will be initiated with gentle brushing with soft toothbrush in coronal direction after suture removal. 4)Each patient will be instructed for proper oral hygiene measure at each appointment. All the parameters will be re-evaluated at 3 months and 6 months after surgery by the second blinded operator. |