CTRI

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CTRI Number

CTRI/2019/08/020839 [Registered on: 22/08/2019] Trial Registered Prospectively

Last Modified On:

24/11/2020

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Biological
Surgical/Anesthesia
Dentistry

Study Design

Randomized, Parallel Group Trial

Public Title of Study

Covering of exposed tooth roots with chorion membrane by different minimal traumatic surgical techniques

Scientific Title of Study

Comparing treatment outcomes of VISTA and modified VISTA in multiple adjacent gingival recession with chorion membrane - A randomized control trial.

Trial Acronym

VISTA v/s mVISTA

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Raghavendra S Medikeri
Designation	Professor
Affiliation	Sinhgad Dental College and Hospital, Pune
Address	Dept No: 04, Department of Periodontology, Sinhgad Dental College and Hospital, S. No-44/1, Vadgaon (Bk.), Off Sinhgad road, Pune - 411041 Maharashtra Pune MAHARASHTRA 411041 India
Phone	9766337620
Fax
Email	dr_raghum2000@yahoo.com

Details of Contact Person
Scientific Query

Name	Dr Raghavendra S Medikeri
Designation	Professor
Affiliation	Sinhgad Dental College and Hospital, Pune
Address	Department no: 04, Department of Periodontology, Sinhgad Dental College and Hospital, S.No-44/1, Vadgaon (Bk.), Off Sinhgad road, Pune - 411041 Maharashtra. Pune MAHARASHTRA 411041 India
Phone	9766337620
Fax
Email	dr_raghum2000@yahoo.com

Details of Contact Person
Public Query

Name	Dr Marisca Austin Pereira
Designation	Post graduate Research student
Affiliation	Sinhgad Dental College and hospital
Address	Sinhgad Dental College and Hospital S.No-44/1 Off Sinhgad road Pune Maharashtra 411041 Mumbai (Suburban) MAHARASHTRA 411041 India
Phone	7620618476
Fax
Email	austin31@rediffmail.com

Source of Monetary or Material Support

Dr. Marisca AP, Department of Periodontology, Dept No: 04, Sinhgad Dental College and Hospital, STEs campus, S.no: 44/1, Vadgaon (Bk), Off Sinhgad Road, Pune - 411041, Maharashtra.

Primary Sponsor

Name	Dr Marisca Austin Pereira
Address	Post-graduate research fellow, Dept no: 04, Department of Periodontology, Sinhgad Dental College and Hospital, S.No-44/1, Vadgaon (Bk.), Off Sinhgad road, Pune - 411041, Maharashtra
Type of Sponsor	Other [Self]

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Raghavendra S Medikeri	Sinhgad dental college and hospital	Dept No: 4, Department of Periodontology, Sinhgad dental college and hospital S.No. 44/1 off Sinhgad road Vadgaon budruk Pune 411041 Pune MAHARASHTRA Pune MAHARASHTRA	9766337620 dr_raghum2000@yahoo.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Sinhgad Dental College and Hospital	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Healthy Human Volunteers	Systemically healthy participants in the age group of 18 years and above, having Millers Class I and /or Class II gingival recession on adjacent multiple teeth with identifiable CEJ

Intervention / Comparator Agent

Type	Name	Details
Intervention	modified VISTA with Chorion Membrane	supraperiosteal tunnel flap is raised, the site is grafted with chorion membrane and flap and/or chorion membrane is stabilised with sutures
Comparator Agent	VISTA with chorion membrane	Subperiosteal tunnel flap is raised, the site is grafted with chorion membrane and flap and/or chorion membrane is stabilized with suture

Inclusion Criteria

Age From	18.00 Year(s)
Age To	60.00 Year(s)
Gender	Both
Details	1. Identifiable CEJ. 2. Age -18 years and above. 3. Millers Class I and/or Class II multiple adjacent ginigval recession on the facial surface. 4. Patients who have given written informed consent after explanation of the surgical procedure.

ExclusionCriteria

Details

1. Subjects taking drugs known to interfere with wound healing
2. Subjects who had received periodontal treatments in previous six months
3. Pregnant/Lactating women
patients with systemic disorders/ condition that are contraindicated for the surgical procedure
4. Patients refusing to give their consent for the surtgical procedure
5. Dental malocclusion such as tooth/ teeth rotations , teeth alignment out of arch.

Method of Generating Random Sequence

Coin toss, Lottery, toss of dice, shuffling cards etc

Method of Concealment

Centralized

Blinding/Masking

Participant, Investigator and Outcome Assessor Blinded

Primary Outcome

Outcome	TimePoints
To evaluate clinical root coverage, probing depth,clinical attachment level,width of keratinized tissue, gingival recession depth,gingival biotype	Baseline and atleast 3 months post-operative.

Secondary Outcome

Outcome	TimePoints
Patient comfort, complications such as hematoma, pain, swelling, etc.	baseline and postoperative 3 months atleast.

Target Sample Size

Total Sample Size="46"
Sample Size from India="46"
Final Enrollment numbers achieved (Total)= "52"
Final Enrollment numbers achieved (India)="52"

Phase of Trial

Phase 3/ Phase 4

Date of First Enrollment (India)

26/08/2019

Date of Study Completion (India)

28/02/2020

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Date Missing

Estimated Duration of Trial

Years="1"
Months="0"
Days="0"

Recruitment Status of Trial (Global)
Modification(s)

Not Applicable

Recruitment Status of Trial (India)

Completed

Publication Details

NIL

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Brief Summary

Gingival recession is a apical migration of gingival margin beyond the cementoenamel junction (CEJ). Connective tissue graft (CTG) technique is most commonly used free soft tissue graft and is considered to be the gold standard though it has its own limitation which include a second surgical site and technique sensitive procedure.1It has predictability of 100% in achieving complete root coverage.

Chorion membrane a foetal membrane is a biomaterial that can be easily obtained, processed and transported. It has gained importance because of its ability to reduce scarring and inï¬‚ammation; enhance wound healing; and serve as a scaffold for cell proliferation and differentiation as a result of its antimicrobial properties.The matrix of chorion contains abundant growth factors such as keratinocyte growth factors , basic fibroblast growth factors, transforming growth factor- Î² that promote periodontal regeneration. The ability of autograft to self-adhere eliminates the need of suturing.

VISTA is a careful subperiosteal dissection that reduces the tension of the gingival margin during coronal advancement while at the same time maintaining the anatomical integrity of the interdental papillae by avoiding papillary reflection. Treatment of millers class I and II using VISTA technique offers improved esthetic outcomes as well as shows complete root coverage over long follow up periods.

Modified vestibular incision supraperiosteal tunnel access technique (modified VISTA) is a minimally invasive technique known to treat multiple gingival recession compared to other techniques.Till date, there are no clinical studies on modified VISTA for root coverage procedures around natural teeth using chorion membrane. The scope and further applications of the chorion membrane in root coverage needs to be studied.

Hence, this study is undertaken to evaluate short term treatment effects of root coverage using chorionic membrane in multiple Millerâ€™s Class I and/or II gingival recession with VISTA compared to modified VISTA.

Research Question :-

Is there any difference in terms of complete root coverage with modified VISTA and VISTA with chorion membrane in Millerâ€™s Class I and/or Class II multiple adjacent gingival recession?