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CTRI Number  CTRI/2017/08/009354 [Registered on: 11/08/2017] Trial Registered Retrospectively
Last Modified On: 10/08/2017
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Single Arm Study 
Public Title of Study   Surgical covering of the exposed tooth root using dehydrated amniotic membrane in the lower front teeth 
Scientific Title of Study   Evaluation Of Dehydrated Amniotic Membrane (Amnioguard®) On Root Coverage Of Lower Anteriors- A Clinical Study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dedeepya Gudivada 
Designation  Post Graduate Student 
Affiliation  JSS Dental College and Hospital 
Address  ROOM NO 9,Department Of Periodontology,JSS Dental College and Hospital,S.S.Nagar

Mysore
KARNATAKA
570015
India 
Phone  9986176328  
Fax    
Email  gdeepya@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  DrSheela Kumar Gujjari 
Designation  Professor & H.O.D 
Affiliation  jss dental college and hospital 
Address  Room no.9,Department of Periodontology,JSS Dental college,S.S.Nagar
s.s.nagar
Mysore
KARNATAKA
570015
India 
Phone  9986176328  
Fax  08212335555  
Email  sheelagujjari@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dedeepya Gudivada 
Designation  post graduate student 
Affiliation  jss dental college and hospital 
Address  Room no.9, Department of periodontology, JSS Dental College and Hospital, S.S.Nagar

Mysore
KARNATAKA
570015
India 
Phone  9986176328  
Fax  08212335555  
Email  gdeepya@yahoo.com  
 
Source of Monetary or Material Support  
Biocover Laboratories 716-L, Model Town, Karnal, Haryana 132001 JSS Dental College and Hospital 
 
Primary Sponsor  
Name  JSS Dental College and Hospital 
Address  Room no 9 JSS Dental College and Hospital S.S Nagar Mysore 
Type of Sponsor  Research institution and hospital 
 
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 
Dedeepya Gudivada  JSS Dental College and Hospital  Room no 9 Department of Periodontology JSS Dental College and Hospital S S Nagar
Mysore
KARNATAKA 
9986176328

gdeepya@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
jss dental college institutional ethical committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Gingival Recession,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dehydrated Amniotic Membrane Amnio guard  Biocover Laborateries Karnal 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Patients who had signed an informed consent.
2. Patients who were systemically healthy patients, both males and females in the age range of 18-50 years.
3. Patients with recession in the mandibular anterior region with Miller’s class I or II gingival recessions.
4. Patients with recession depth of ≥3mm but less than 5mm.
5. Patients with well aligned teeth.
6. Patients who were able to and willing to follow study procedures and instructions.
7. Patients who were compliant and maintained good plaque control.
 
 
ExclusionCriteria 
Details  1. Patients who did not provide consent for the study.
2. Patients who had gingival recession (class III and IV) with interdental bone loss.
3. Thin gingival biotype (<1.5mm gingival thickness)
4. Teeth with restored cervical abrasions.
5. Pregnant/lactating women.
6. Patients who were known smokers or who were using smokeless tobacco.
7. Patients who had root caries.
8. Patients with any immunologic disease and who are currently receiving or have received within two months prior to study entry, systemic corticosteroids, immunosuppressive agents, radiation therapy, and/or chemotherapy which would compromise wound healing and preclude periodontal surgery.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the regenerative potential of dehydrated amniotic membrane using the following clinical parameters:
Percentage of root coverage
Gain in width of keratinized gingiva
Improvement in clinical attachment level
 
At 1 week ,3months and 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
2. To assess esthetic outcome following the use of dehydrated amniotic membrane.  6 months 
 
Target Sample Size   Total Sample Size="10"
Sample Size from India="10" 
Final Enrollment numbers achieved (Total)= "10"
Final Enrollment numbers achieved (India)="10" 
Phase of Trial   N/A 
Date of First Enrollment (India)   20/02/2015 
Date of Study Completion (India) 04/10/2016 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Gingival recession, as described by the American Academy of Periodontology is the displacement of marginal periodontal tissues apical to the cementoenamel junction causing exposure of root.

Gingival recession is a very common finding in all the populations irrespective of age and ethnicity. It mostly occurs due to plaque accumulation resulting in inflammation of gingival tissues. Many other risk factors cause recession which include developmental defect such as bone dehiscence, chronic trauma due to impaction of foreign bodies against the gingiva, frictional injury to the gingiva, abnormal tooth brushing, malpositioning of teeth, gingival ablation, abnormal frenal attachment etc. The exposure of the root surface may lead to problems such as root caries, dentinal hypersensitivity and esthetic problem1.

Many treatment modalities such as pedicle grafts, free gingival grafts have been described that can be used in treating gingival recession. Pedicle graft requires an adjacent donor site with adequate attached gingiva, but it is associated with the disadvantage of formation of gingival recession or loss of gingival height at the donor site. Free gingival grafts and subepithelial connective tissue grafts are obtained from the palate. Although free gingival graft has a good predictability it has a disadvantage of unsatisfactory esthetic results. Subepithelial connective tissue graft is currently the gold standard procedure as it has favorable end results with regard to root coverage and esthetic results. Though it is a gold standard procedure, it has a disadvantage that it requires a second surgical site which causes discomfort and pain at the donor site many a times2.To overcome all these short comings the research has led to the finding of alternative treatments which can provide promising results and patient comfort at the same time.

Recently, allograft alternatives to autogenous tissue grafts have been introduced in the form of dermis tissue products eg. (Alloderm®, LifeCell Corporation, Branchburg, NJ, USA). It has significant advantages over the previous freeze dried skin allografts. It is free of all the cell components which are also potential mode of disease transmission. In addition, the integrity of the extracellular matrix is maintained, which was otherwise responsible for inflammatory response associated with the earlier available freeze-dried skin allografts. These unique characteristics make the acellular dermal matrix allograft completely biocompatible and safe. However, the unavailability of this material and cost factor had further made the researchers to look for newer materials which could be readily available3. An additional allograft of alternative origin was derived from human amnion tissue. Though it had been used since 1900’s for skin grafts, burn wounds and ulcers only recently it got recognized in dentistry. It is derived from the amniotic sac that encloses the developing fetus during the gestation and is composed of amnion and chorion tissue.

 Amnion lines the inner most portion of the amniotic sac and consists of a single layer of epithelium cells, thin reticular fibers (basement membrane), a thick compact layer, and a fibroblast layer. The basement membrane contains collagen types III, IV, and V and cell-adhesion bioactive factors including fibronectin and laminins. The amniotic basement membrane closely mimics the basement membrane of human oral mucosa. A particular fact regarding it is that this amnion layer possesses several types of laminins with Laminin-5 being the most prevalent. Laminin-5 plays a role in the cellular adhesion of gingival cells and concentrations of this glycoprotein in amniotic allograft can be useful for periodontal grafting procedures. Amnion tissue also contains growth factors that may aid in the formation of granulation tissue by stimulating fibroblast growth and neovascularization. The cells found within this tissue exhibits characteristics associated with stem cells and they may enhance clinical outcomes of periodontal surgeries4.

 As sparse literature is available regarding the dehydrated amniotic membrane in the field of reconstructive periodontal surgery and very few studies are there related to the treatment of recession in lower anteriors, the current study was aimed to evaluate the clinical efficacy of dehydrated amniotic membrane(Amnio-guard®) in the recession coverage of the mandibular anteriors.

 
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