Brief resume of the intented work: need for the study




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6. BRIEF RESUME OF THE INTENTED WORK:


    1. NEED FOR THE STUDY:

A number of materials have being proposed as being suitable for grafts in vestibuloplasty such as mucosal grafts and skin grafts. However they all have disadvantages, the palatal grafts can provide only limited amount of transplantable mucosa and are associated with patient discomfort at donor site. The skin graft also have disadvantage which include presence of hair, lack of denture adhesion, contraction of graft and the presence of extensive graft donor wound.

To circumvent those disadvantages other biological membranes have been suggested as options including fetal membrane. The amniotic membrane closely resembles the epidermis of the skin. The amnion has been successfully used as wound dressing for burns and as a dressing to promote healing of chronic ulcers of the leg. It has also being used in surgical reconstruction of artificial vagina, for repairing omphaloceles and prevents tissue adhesion in surgeries of abdomen, head and pelvis.

Amniotic membranes have the advantage not only to promote healing, secondary epithelisation but also vascularising healthy granulation tissue. They are anti bacterial and biodegradable and do not cause any immune reactions.




    1. REVIEW OF LITERATURE:

In one of the study, seven subjects who had been referred for preprosthetic surgery underwent mandibular vestibuloplasty using Clark’s technique and amnion as graft material. Fresh amniotic membrane was placed in the area and an acrylic splint was used with soft liner and 0.4-mm wires to cover the surgical site. The area was reexamined after 1 week, 2 weeks, 4 weeks, 3 months, and 6 months. The results show that amniotic membrane might be a favorable graft material for vestibuloplasty, promoting healing and preventing relapse.1


In one of the previous study which was done to determine the blood supply to lyophilized amniotic membranes when used as graft material in vestibuloplasty. 133Xe clearance technique was used to measure the blood flow to the grafts. A total of 20 patients had either Clark (10) or Kazanjian (10) vestibuloplasties. The blood flow was determined at 2-3 days preoperatively and at 10 and 30 days postoperatively. The investigation showed that lyophilized amnion is an appropriate graft material for vestibuloplasty.2

In one of the study, samples of human amnion and skin were preserved in sterile containers of 85% glycerol at 48C for over a year. Dorsal full- thickness or split-thickness skin wounds were produced in rats. The defects were divided into four areas, each of which were covered with preserved amnion, fresh amnion, preserved skin, or left uncovered as a control. The materials on the wounds were evaluated macroscopically and microscopically after 2, 4, 7, 10 and 14 days. Glycerol-preserved amnion was found to be as effective as fresh amnion or skin in terms of decreasing bacterial levels in infected rat burn wounds. Amnion stored in glycerol is reliable and effective for a long period of time.3


In one of the study was done to investigated whether human amnion has the ability to suppress allo-reactive T cell responses in vitro. For mixed lymphocyte reaction (MLR), lymphocytes isolated from lymph nodes of C57BL/6 mice (Mls1b, Vb6+) were cultured with irradiated splenocytes from DBA/2 mice (Mls1a, Vb6-) with or without human AM. The results indicate that human AM has the ability to suppress allo-reactive T cells in vitro. This inhibitory effect likely contributes to the success of the ALT-AMT combination.4


In one study, 150 patients of OSMF were treated with different treatment modalities including medical and surgical fibrotomy of the bands with placement of split-thickness, buccal fat pad and amnion grafts. The results have shown that amnion graft may be useful in giving patients suffering from trismus improved long-term prospects after surgery.5





    1. OBJECTIVE OF THE STUDY:

The purpose of this study is to evaluate the clinical efficacy of amnion as a graft material for vestibuloplasty with a follow up period of 3 months. The vestibular depth, pain and paresthesia will be evaluated at time intervals of 1st week, 2nd week, 4th week and 3rd month.

7. MATERIALS AND METHODS:



    1. SOURCE OF DATA:

Patients reporting to the Department of Oral and Maxillofacial Surgery, P.M.N.M. Dental College and Hospital, Bagalkot for vestibuloplasty.


Inclusion criteria:




  1. Patient indicated for vestibuloplasty.

  2. Patient fit for surgery under local anesthesia

  3. Medically fit patients.

Exclusion criteria:




  1. Immuno-compromised patients.

  2. Uncooperative patient.



    1. METHODS OF COLLECTION OF DATA

Patients reporting to the department of Oral and Maxillofacial Surgery of P.M.N.M Dental College and Hospital, Bagalkot will be selected for study with inform consent for vestibuloplasty.




SAMPLE SIZE: 10 patients.

7.3 DOES THE STUDY REQUIRE ANY INVESTIGATIONS OR INTERVENTIONS TO BE CONDUCTED ON PATIENTS OR OTHER HUMANS OR ANIMALS? IF SO PLEASE DESCRIBE BRIEFLY.
Pre operative Ortho Pantomogram.

Routine blood investigations.




    1. HAS ETHICAL CLEARANCE BEEN OBTAINED FROM YOUR INSTITUTION IN CASE OF 7.3?

Yes.


8. LIST OF REFERENCES:

1. Mohammad Hassan Samandari, Masoud Yaghmaei, Masoud Ejlali, Mohammad Moshref, and Arash Shoja Saffar, Use of amnion as a graft material in vestibuloplasty: A preliminary report. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 2004;97:574-8




  1. R. Gtiler, M. T. Ercan, N. Ulutuncel, H. Devrim, N. Uran :Measurement of blood flow by the 133Xe clearance technique to grafts of amnion used in vestibuloplasty. British Journal of Oral

and Maxillofacial Surgery (1997) 35, 280-283


  1. Tugrul Maral, Huseyin Borman, Hande Arslan, Beyhan Demirhan, Gurler Akinbingol, Mehmet Haberal. Effectiveness of human amnion preserved long-term in glycerol as a temporary

biological dressing. Burns 25 (1999) 625±635



  1. M. Ueta, M.N. kweon, Y. Sano, C. Sotozono, J. Yamada, N. Koizumi, H. Kiyono & S. Kinoshita:Immunosuppressive properties of human amniotic membrane for mixed lymphocyte

reaction. Clin Exp Immunol 2002; 129:464–470



  1. Lai DR, Chen HR, Lin LM, Huang YL, Tsai CC: Clinical evaluation of different treatment methods for oral submucous fibrosis. A 10-year experience with 150 cases.

J Oral Pathol Med 1995; 24: 402-6.







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