| 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
|
|
|
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
|
|
|
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. |