Proforma for registration of subjects for dissertation



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RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA

BANGALORE

ANNEXURE II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION


1.

NAME OF THE CANDIDATE AND ADDRESS

(IN BLOCK LETTERS)

DR. CHANDRASHEKAR RAJU

DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY,M. S. RAMAIAH DENTAL COLLEGE,

BANGALORE-560054


2.

NAME OF THE INSTITUTION


M. S. RAMAIAH DENTAL COLLEGE

BANGALORE



3.

COURSE OF STUDY AND SUBJECT

MASTER OF DENTAL SURGERY(MDS)

ORAL AND MAXILLOFACIAL SURGERY



4.

DATE OF ADMISSION OF COURSE


27-07-2013

5.

TITLE OF THE TOPIC

EFFICACY OF INWARD FRAGMENTATION TECHNIQUE VERSUS



CONVENTIONAL TECHNIQUE IN THE SURGICAL REMOVAL OF IMPACTED MANDIBULAR THIRD MOLAR”


6.

Brief resume of intended work



    1. Need for the study:

The extraction of impacted mandibular third molars is one of the most commonly performed minor procedures in Oral and Maxillofacial surgery. It involves the manipulation of both soft and hard tissues causing immediate post-operative sequelae. Conventional surgical extraction of impacted mandibular third molar requires lateral and distal bone removal to allow mobilization of the tooth. Morbidity following third molar surgery is currently being discussed with the aim of reducing intraoperative as well as postoperative complications. Recently a shift in paradigms can be observed towards atraumatic techniques in third molar surgery. In this regard, a new technique called inward fragmentation technique (IFT) has evolved in selective cases of third molar impactions which does not involve rising of flap or bone removal.

Evidence regarding the efficacy of IFT is sparse, therefore this study aims to compare the outcomes of conventional technique versus IFT in the surgical removal of impacted mandibular third molars.






    1. Review of literature:

Third molar extraction remains one of the most ubiquitous procedures performed by oral and maxillofacial surgeons, and most third molar surgeries are performed without intra or post-operative difficulties. In all surgical procedures, proper preoperative planning and the blending of surgical technique with surgical principles is of paramount importance for decreasing the incidence of complications. They may occur intraoperatively or develop in the postoperative period. The four most common postoperative complications of third molar extraction reported in the literature are localized alveolar osteitis (AO), infection, bleeding, and paresthesia. Surgical removal of third molars is often associated with postoperative pain, swelling, and trismus 1, 2.

Accessibility is a key issue in removal of impacted teeth. A full-thickness mucoperiosteal flap must be elevated to allow for visualization and placement of retractors, drilling equipment, elevators, and forceps. The lower third molar incision most commonly used is an envelope flap that extends from the mesial of the first molar to the ramus with lateral divergence of the posterior extension to avoid lingual nerve injury. With this flap an anterior vertical releasing incision at the distal aspect of the first or second molar is made. In either flap design the incision must be full thickness. The extent of the flap reflection should be limited to the external oblique ridge laterally. Reflecting beyond this point leads to increased dead space and more edema.3

Adoption of bone removal plus tooth section technique minimizes the possibility of exerting too much pressure when removing wisdom teeth. Merely removing bone and extracting or elevating a wisdom tooth afterwards causes it to hinge at its apex. Removing bone to the level of the cement enamel junction of the tooth is useful for access as well as enabling us to section the tooth into several segments. Having more tooth segments reduces the tooth size and the possibility of hinging the root over inferior alveolar nerve. This is because the segments are taken out one by one, leaving the apical portion with plenty of space coronally for the root segment to be elevated.4

Extraction of an impacted mandibular third molar may result in a temporary or permanent injury of the IAN. Although the incidence of such a complication is relatively low, its frequency increases as the roots of the impacted tooth move closer to the IAN. To overcome the risk of IAN injury, intentional odontectomy has also been proposed.5

The morbidity rates involving different methods frequently used for surgical removal of impacted third molars are not completely resolved. The use of a surgical method with minimum postoperative complication is needed.6

Modern Dentistry is based on conservative thinking taking into consideration that the reason for lateral and distal bone removal for mandibular third molar extraction is to allow an outward directed mobilization, a modern technique should provide a technical solution which preservation of the mandibular architecture without the removal of bone necessary for outward mobilization. This may be achieved by systematic and precise space making procedure in order to provide stepwise fragmentation and inward mobilization of the tooth.7



    1. Objectives of the study

To evaluate two different techniques in terms of:

  1. Duration of surgery

  2. Bone height in relation to operative site

  3. Post-operative sequelae

  4. Limitations of inward fragmentation technique if any

7.

Materials And Methods:




    1. Source of data

Patients reporting to the Department of Oral and Maxillofacial Surgery, M. S. Ramaiah Dental College and Hospital requiring bilateral surgical removal of impacted mandibular third molars.
Sample size: Fixing alpha at 5% and beta at 20% and to have power of the study at 80%, estimated sample size is 15.
Type of study: A randomized controlled clinical study
Inclusion criteria

  • Healthy individuals in the age group of 18-35 years with bilaterally impacted mandibular third molars.

  • Mandibular third molar completely or partially impacted with the absence of acute inflammatory symptoms.


Exclusion criteria

  • Horizontally impacted mandibular third molars

  • Patients in whom the second molar is missing or is indicated for extraction

  • Subjects with any underlying systemic disease or compromised immunity

  • Pregnant women and lactating mother







    1. Method of collection of data.

After pre-operative evaluation and obtaining written informed consent, all the patients included in the study will be allocated into two groups as follows:

Group A: Patients undergoing surgical removal of impacted mandibular third molar by Conventional Technique on one side.

Group B: Patients undergoing removal of the impacted mandibular third molar using the Inward Fragmentation Technique on the opposite side.

All the patients undergoing surgical procedure will be advised a 5 day course of oral antibiotic and analgesic. Patients will be advised to take soft diet for 3 days and rinse oral cavity using chlorhexidine mouth wash for 7 days postoperatively.



Follow up:

Patients will be evaluated for the following parameters:



  • Preoperative

1.Type of impaction

a. Clinical

b. Radiological

2. Mouth opening

Measurement of inter-incisal distance using a divider and scale.

3. Baseline measurement to assess post operative swelling by measuring distance between

Point A :- Tragus and soft tissue pogonion

Point B :- Tragus and lateral corner of mouth

Point C :- Lateral corner of the eye and angle of mandible

4. Bone height

In relation to impacted third molar using Panoramic radiograph (OPG).



  • Intraoperative: Duration of surgery

  • Post operative: The following parameters are assessed on day 1, day 3 day 7 and after 1 month.

1. Pain:- using Visual analogue scale

2. Mouth opening: - Measurement of inter-incisal distance using a divider and scale.

3. Swelling:- Measuring distance between

Point A :- Tragus and soft tissue pogonion

Point B :- Tragus and lateral corner of mouth

Point C :- Lateral corner of the eye and angle of mandible

4. Bone height

In relation to operative site using Panoramic radiograph (OPG).



5. Assessment of delayed healing or infection
STATISTICAL TESTS:

  • Student’s t-test would be employed to compare all the parameters between experimental and control sides.

  • Repeated measures ANOVA would be used to assess the change in parameters in different time intervals.




    1. Does the study require any investigations or interventions to be conducted on the patients or other humans or animals? ( If so please describe briefly)

YES.

Investigations:

  • Intraoral periapical radiograph

  • Panoramic radiograph (OPG)



Interventions:

  • All patients will undergo routine oral prophylaxis prior to the surgical procedure

  • A written informed consent will be taken from the patient prior to surgical removal of impacted mandibular third molar.




    1. Has Ethical clearance been obtained from your institution in case of 7.3?

YES





















































8.

List Of References




  1. Gary F. Bouloux, Martin B. Steed, Vincent J. Perciaccante, Complications of Third Molar Surgery, Oral Maxillofacial Surg Clin N Am 19 (2007); 117–128




  1. Abel Garcia Garcia, Francisco Gude Sampedro, Jose Gandara Rey, Mercedes Gallas Torreira: Trismus and pain after removal of impacted lower third molars, J Oral Maxillofac Surg 55:1223-1226, 1997




  1. Sam E. Farish, Gary F. Bouloux, General Technique of Third Molar Removal , J Oral Maxillofacial Surg Clin N Am 19 (2007) 23–43




  1. Ngeow WC; Tooth section technique for wisdom teeth, Int J Oral Maxillofac Surg 38:908, 2009




  1. Landi L,Manicone PF,Piccinelli S,Raja A,Raja R:A novel surgical approach to impacted mandibular third molars to reduce the risk of paresthesia;a case series, J Oral Maxillofac Surg 68(5):969-974, 2010




  1. Praveen G,Rajesh P,Neelakandan RS,Nandagopal CM: Comparison of morbidity following the removal of mandibular third molar by lingual split,surgical bur and simplified split bone technique. Indian J Dent Res 2007;18:15-8.




  1. Engelke W,et al.,Removal of impacted mandibular third molars using an inward fragmentation technique(IFT)-Method and first results,journal of cranio-maxillo-facial surgery(2013) 1-7.






INFORMED CONSENT
TITLE: “EFFICACY OF INWARD FRAGMENTATION TECHNIQUE VERSUS CONVENTIONAL TECHNIQUE IN THE SURGICAL REMOVAL OF IMPACTED MANDIBULAR THIRD MOLAR”


UNDERTAKING BY THE INVESTIGATOR:
Your consent to participate in the above study is sought. You have the right to refuse consent or withdraw the same during any part of the study without giving any reason. We undertake to maintain complete confidentiality regarding the identity of the subjects and the information obtained from the subject/patient during the course of the study. We assure that all the standard infection control precautions will be strictly adhered to throughout the study. If you have any doubts regarding the study, please feel free to clarify the same. Even during the study, you are free to contact any of the investigators for clarification if you desire. The list of investigators and their contact numbers are below:
Dr. Chandrashekar raju Dr. K .Ranganath

9448668386 9844181097


CONSENT

I _________________________________the undersigned hereby authorize Dr.___________________________at M. S. Ramaiah Dental College and Hospital to perform upon me the following procedure(s) for research purpose:


1. Surgical removal of impacted mandibular third molar by Conventional Technique on one side and Inward Fragmentation Technique on the opposite side. All the patients undergoing surgical procedure will be advised a 5 day course of oral antibiotic and analgesic. Patients will be advised to take soft diet for 3 days and rinse oral cavity using chlorhexidine mouth wash for 7 days postoperatively.
The above procedure along with the purpose of the study has been explained to me in detail in intelligible terms. I have received appropriate response to all my doubts and clarifications. I understand that I will be exposed to radiation dose twice or more during the course of the study. I also understand that photographs will be taken in the course of the study and that the results generated from this study can be published in scientific literature, for which I do not have any objections. I have understood that I have the right to refuse my consent or withdraw it at any time during the study.

I understand that signing this consent form indicates that I voluntarily agree to participate in this study.


I confirm that I understand the information presented in this consent form.

Signature of Participant

Date:

Place:


Signature of Witness
Date:

Place:


Signature of the investigator 1 (Dr. Chandrashekar Raju)

Date:


Place:
Signature of the investigator 2 (Dr. K. Ranganath)
Date:

Place:


M. S. RAMAIAH DENTAL COLLEGE AND HOSPITAL

IMPACTED TOOTH REMOVAL PROFORMA

Name: O.P.No.: Date:

Age: Sex: Occupation:

Address:

CHIEF COMPLAINT:

HISTORY OF PRESENT ILLNESS:

H/O PERICORONITIS/ABSCESS:

ANY TREATMENT RECEIVED: Y/N

IF YES, PLEASE SPECIFY:

DENTAL HISTORY:

MEDICAL HISTORY:

DRUG ALLERGY:

CLINICAL EXAMINATION:

EXTRAORAL:

  • Facial symmetry:



  • Mouth opening(using scale and divider):



  • Micrognathia:



  • Macrognathia:



  • Normal:

INTRAORAL:

Impacted tooth: Surrounding soft tissue:

  • Inflammed/Normal



  • Ulcer: Present/Absent



  • Fibrosed: Y/N



  • Completely covered by soft tissue or partially exposed:

Pericoronitis:

  • Acute infection if any:



  • Swelling:



  • Discharge:



  • Pain/ Difficulty in chewing:



  • No. of episodes:

Condition of adjacent mandibular second molar:

  • Any caries:



  • Periodontal involvement:



  • RCT: Y/N

Upper tooth:

  • Present/Absent



  • Impinging on soft tissue: Y/N



  • Position: Normal/Buccal/Supra erupted

Tongue: Macro/Micro/Normal

INVESTIGATIONS:

  • IOPAR:



  • OPG:

Radiographic and Clinical co-relation:

Tooth impaction: Y/N

DIAGNOSIS:

CLASSIFICATION:

WAR LINES:

WHARF ASSESSMENT:

TREATMENT PLAN:

TREATMENT DONE:

Surgical method:

Block given:

Incision:

Procedure:

Duration:

Medication:

Follow up and complications:


TABLE 1: Preoperative parameters


Type of impaction







Interincisal distance







Baseline measurement







Radiographic assessment of bone height








TABLE 2: Intraoperative parameters


Duration of Surgery








TABLE 3: Post operative parameters


Parameters

Day 1

Day 3

Day 7

1 Month

Pain













Swelling













Inter-incisal distance













Infection













Radiographic assessment of bone height













Additional findings














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