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

Phase 3

Completed

• Conditions: 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

• Registration Number: CTRI/2019/08/020839
• Lead Sponsor: Dr Marisca Austin Pereira

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 inflammation; 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- β 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 Miller’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 Miller’s Class I and/or Class II multiple adjacent gingival recession?

Detailed Description

Not available

Study Timeline

• Study Start: 2019-08-26
• Study Completion: 2020-02-28
• Last Update Posted: 2020-11-24

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

• Identifiable CEJ.
• Age -18 years and above.
• Millers Class I and/or Class II multiple adjacent ginigval recession on the facial surface.
• Patients who have given written informed consent after explanation of the surgical procedure.

Exclusion Criteria

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
Patient comfort, complications such as hematoma, pain, swelling, etc.	baseline and postoperative 3 months atleast.

Trial Locations

Locations (1)

Sinhgad dental college and hospital; 🇮🇳 Pune, MAHARASHTRA, India

Sinhgad dental college and hospital

🇮🇳Pune, MAHARASHTRA, India

Dr Raghavendra S Medikeri

Principal investigator

9766337620

dr_raghum2000@yahoo.com