FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/08/056587 [Registered on: 17/08/2023] Trial Registered Prospectively
Last Modified On: 14/08/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of different materials for the treatment of lowering of gums 
Scientific Title of Study   Comparative evaluation of Sub-epithelial connective tissue graft and Xenogenic collagen membrane in the treatment of gingival recession: A Randomised controlled 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. Shweta Ahlawat 
Designation  Academic junior resident 
Affiliation  Institute of Medical Sciences, Banaras Hindu University 
Address  Room no-5, Division of Periodontology, Department- Faculty of Dental Sciences, IMS BHU, Varanasi-221005

Varanasi
UTTAR PRADESH
221005
India 
Phone  7976734778  
Fax    
Email  shweta.ahlawat2@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Sarita Parihar 
Designation  Professor 
Affiliation  Institute of Medical Sciences, Banaras Hindu University 
Address  Room no-5, Division of Periodontology, Department- Faculty of Dental Sciences, IMS BHU, Varanasi

Varanasi
UTTAR PRADESH
221005
India 
Phone  8004925677  
Fax    
Email  drsarita6@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr. Shweta Ahlawat 
Designation  Academic junior resident 
Affiliation  Institute of Medical Sciences, Banaras Hindu University 
Address  Room no-5, Division of Periodontology, Department- Faculty of Dental Sciences, IMS BHU, Varanasi

Varanasi
UTTAR PRADESH
221005
India 
Phone  7976734778  
Fax    
Email  shweta.ahlawat2@gmail.com  
 
Source of Monetary or Material Support  
Faculty of Dental Sciences, IMS BHU, Varanasi 
 
Primary Sponsor  
Name  Shweta Ahlawat 
Address  Unit of Periodontology, Faculty of Dental Sciences, IMS BHU, Varanasi-221005 
Type of Sponsor  Other [Self Sponsoring] 
 
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 Shweta Ahlawat  Faculty of Dental Sciences, Institute of medical sciences, Banaras Hindu University  Room no-5, Division of Periodontology, Department-Faculty of Dental Sciences, Institute of Medical Sciences, Banaras Hindu University, Varanasi
Varanasi
UTTAR PRADESH 
7976734778

shweta.ahlawat2@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Institute of Medical Sciences, Banaras Hindu University  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Teeth with gingival recession  
Patients  (1) ICD-10 Condition: K060||Gingival recession,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Evaluation of sub-epithelial connective tissue graft in the treatment of gingival recession  Graft is obtained from palate. Dimensional changes are observed before the surgical procedure, after 3 months, and at 6 months. 
Intervention  Xenogenic collagen membrane in the treatment of gingival recession  Dimensional changes are observed before the surgical procedure, after 3 months, and at 6 months 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1. Systemically healthy subjects with class I (Marginal tissue recession, which does not extend to the mucogingival junction (MGJ)) /II (Marginal tissue recession extending to or beyond mucogingival junction (MGJ) with no radiographic sign of bone loss and requiring surgical intervention for root coverage)
2. Probing pocket depth <3mm
3. No prior history of any surgical procedures on the site to be treated.
4. Presence of detectable CEJ.
5. Not using tobacco in any form.
6. Systemically healthy subjects with no contraindication to periodontal surgery.
7. Able to achieve good oral hygiene.
8. Subjects who gave written consent.
9. Subjects who were available for follow up.
 
 
ExclusionCriteria 
Details  1. Persistence of uncorrected gingival trauma from tooth brushing.
2. Presence of severe tooth malposition, rotation or clinically significant supraeruption.
3. Cervical or root caries, cervical abrasion, prosthetic crown and restorations involving cemento-enamel junction.
4. Pregnant and lactating mothers.
5. Hypersensitivity or allergy to the collagen based medical products. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Coverage of gingival recession in terms of both recession depth & width  Baseline, & at 3 & 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Gain in keratinised tissue width, Clinical attachment level, Probing Depth
and attached gingiva thickness
 
Baseline, & at 3 & 6 months 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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 3/ Phase 4 
Date of First Enrollment (India)   31/08/2023 
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="0"
Months="8"
Days="15" 
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  

According to Glossary of Periodontal terms (2001), gingival recession is defined as the apical displacement of gingival margin in relation to cement enamel junction. One of the common clinical findings in periodontal disease is gingival recession. The attachment loss is because of the collapse of gingival tissue and destruction of periodontal connective tissue.

Various factors like plaque induced inflammation, trauma, high frenum attachment, traumatic brushing, lack of alveolar bone due to lip and tongue piercing, dehiscence, orthodontic movement, ageing, abnormal tooth position in the dental arch, iatrogenic factors, biologic width violation, smoking and tobacco chewing habits have been suggested as etiological factors for gingival recession. Gingival recession carries with itself not only aesthetic discrepancies but also leads to exposure of root surface. The exposure of root surface is associated with root hypersensitivity, difficulties in achieving optimal plaque control and development of root caries. Therefore, procedures involved in the treatment of gingival recession improve aesthetics by restoring natural tissue blending. These procedures also increase the thickness of soft tissues that facilitate plaque control and prevent periodontal breakdown and development of root caries.

As one of the greatest aesthetic concerns associated with the periodontal tissues is gingival recession, research is going on to find treatment modalities to address all the biological and functional problems. This has led to the development of several new and modified surgical techniques. There are various surgical techniques and their modifications for the treatment of gingival recession. Surgical procedures used in the treatment of recession defects may be categorised as coronally advanced flap, pedicle soft tissue grafting procedures (lateral sliding flap, double papilla flap), coronally repositioned flap and free soft tissue grafting procedures such as epithelialized grafts or subepithelial connective tissue grafts.

SCTG helps in improved long-term stability of complete root coverage (CRC) and it is accepted as the gold standard in the treatment of gingival recessions. However, the requirement of a second surgical site, limited amount of graft, rather low patient tolerance and high complication rates in donor area are the major disadvantages of SCTG. To reduce these disadvantages, barrier membrane, platelet-rich plasma, platelet-rich fibrin, enamel matrix derivatives and graft substitute materials have been used as an alternative to SCTG.

Periodontal connective tissue predominantly consists of type 1 collagen fibres. Thus, researchers developed many different kinds of collagen membranes for using as grafting material using type 1 collagen as the major component. The additional benefits of collagen material is hemostasis, chemotaxis for periodontal fibroblasts, gingival fibroblasts, weak immunogenicity, easy manipulation and ability to augment tissue thickness. Hence, collagen appears as an ideal choice for use in guided tissue regeneration procedures and soft tissue grafting.

Recently, a new xenogeneic collagen membrane (XCM) has been used in periodontal regenerative procedures. It is highly biocompatible and contains purified intact collagen. It has high mechanical strength. Also, it is soft and very drapable, yet repositionable for precise adjustment and placement. It has an additional advantage that it does not stick to instruments. Hence, XCM seems to be a promising soft tissue graft substitute. It is not only less invasive and time saving but also provides unlimited off-the-shelf supply of graft material and has been cleared by U.S. Food and Drug Administration (FDA). Very few studies have been done on the use of XCM for root coverage procedures. Hence, the present research work aims to evaluate and compare SCTG and XCM in the treatment of gingival recession using the modern alteration of coronally advanced tunnel technique.

In our study, we aim to evaluate and compare the clinical efficacy of XCM to SCTG in the treatment of Miller’s class I / class II gingival recession.


 
Close