Periotome As An Aid To Atraumatic Extraction In Orthodontic Mandibular Single Rooted Tooth: A Split-mouth Study.

BRIEF RESUME OF INTENDED STUDY

NEED OF THE STUDY -The specialty of maxillofacial surgery has made tremendous strides in the past few decades encompassing such diverse fields as craniofacial surgery, micro-vascular reconstruction, etc. But the most commonly performed procedure by maxillofacial surgeons in many countries continues to be exodontia, comprising non-surgical routine tooth extractions as well as impacted tooth removal. Improvements in local anesthetics as well as its delivery armamentarium have resulted in painless extractions but the fear of post extraction pain deters many patients from undergoing this procedure. Soft tissue trauma is one of the reasons for post extraction pain and various techniques have been tried to reduce this component’s contribution. With the advent of implantology, atraumatic extraction has come into vogue again and proponents of periotome have claimed that it not only reduces soft tissue injury but also aids in salvaging the bony integrity of the socket as well.

AIM & OBJECTIVES:

AIM -The aim of this study is compare and to evaluate the efficacy of periotome in orthodontic mandibular single rooted nonsurgical tooth extractions with conventional mandibular single rooted nonsurgical tooth extractions.

OBJECTIVE -The objective of this study is to assess the efficacy of periotome in orthodontic mandibular single rooted nonsurgical tooth extractions with orthodontic mandibular conventional single rooted nonsurgical tooth extractions with regards to following parameters:

• Pain was assessed using visual analogue scale all throughout 7 days postoperatively.

• Gingival laceration.

• duration of procedure.

• number and frequency of analgesics consumed and

• complications (if present) were also noted

MATERIALS AND METHOD MATERIALS

A split mouth study will be performed in 50 patients. All patients will undergo the non-surgical extractions of orthodontic bilateral mandibular single rooted teeth. Before enrolment, the objectives, implications and possible complications of this clinical trial were explained to all the patients and informed consent was obtained. The patients did not receive any financial compensation for participating in the study. Following armamentarium and materials will be required for this study –

• Periotome extraction kit.

• Orthopantomogram.

• 2% lignocaine hydrochloride with 1:80,000 adrenaline (LIGNOX 2%, INDOCO REMEDIES LTD).

• Disposable 3 ml syringe and needle.

• Conventional extraction forceps / kit.

METHODOLOGY:

TYPE OF STUDY Prospective interventional Split- mouth study.

SOURCE OF THE DATA

The study will be conducted in the Department of Oral and Maxillofacial Surgery at Chhattisgarh Dental College and Research Institute, Rajnandgaon, Chhattisgarh 491441.

SAMPLING TECHNIQUE Non-randomized - Convenience sampling technique.

SAMPLE SIZE CALCULATION

The sample size calculation was done using G*Power 3.1.9.2 software. Parameters used in calculation: Effect size d = 0.59 α err prob = 0.05 Power (1-β err prob) = 0.90 Allocation ratio N2/N1 = 1 Non-centrality parameter δ = 2.9500000 Critical t = 1.6605512 Df = 98 Considering 5% alpha error and 90% power for the study, the total sample size for this study is 100

METHOD OF COLLECTION OF DATA

The study will consist of 50 patients reporting to the Department of Oral and Maxillofacial Surgery at Chhattisgarh Dental College and Research Institute who will be undergone for orthodontic bilateral mandibular single rooted Non-surgical extraction.

Group A(control group): orthodontic mandibular single rooted Non-surgical extraction with conventional periosteal elevator followed by extraction by conventional forceps.

Group B(test group): orthodontic mandibular single rooted Non-surgical extraction with periotome kit followed by extraction by conventional forceps. The case selection will be done after obtaining detailed case history, clinical examination and radiographic assessment using orthopantomogram and intraoral periapical radiographs. Patients will be explained about the study and asked to sign an informed consent form.

CRITERIA FOR SELECTION OF PATIENT INCLUSION CRITERIA

• Bilateral orthodontic mandibular single rooted tooth extraction.

• 18-30 years of age group.

• American Society of Anesthesiologists (ASA) type I. A normal healthy patient, non-smoking, no or minimal alcohol use, (no acute or chronic disease).

• Patients willing for extraction and participating in the study.

EXCLUSION CRITERIA

• Dilacerated , multi-rooted, endodontically compromised tooth.

• patients who were taking drugs which interfere with pain response.

• Allergy to ketorolac tromethamine, lignocaine and adrenaline.

• Periodontally compromised tooth / patients suffering from localized/generalized periodontitis.

• Pregnant and lactating females and patients on oral contraceptives.

• Medically compromised patients.

• Tobacco chewers and smokers.

• Patients requiring repeated injection of local anesthetics.

STUDY DESIGN

In all patients a detailed case history will be taken to rule out any systemic conditions that contraindicate orthodontic mandibular single rooted non-surgical extraction and the use of local anesthesia with adrenaline. The patient will be explained about the study and will be required to sign a consent form showing their approval for the study. Group A: will consist of 50 samples who will undergone for orthodontic mandibular single rooted non-surgical extraction with conventional periosteal elevator followed by extraction by conventional forceps. Group B: will consist of 50 samples who will undergone for single rooted non-surgical extraction with periotome kit followed by extraction by conventional forceps.

SURGICAL PROCEDURE

Tooth extractions will be carried out aseptically under local anesthesia (2 % lignocaine with 1:80,000 adrenaline) and post extraction instructions Will be given to each patient. In the control group A, after clinical assessment of tooth to be extracted periosteal elevator will be used for reflecting the gingiva to expose the cemento-enamel junction and the extraction will be carried out using conventional forceps. In the test group B, after clinical assessment of tooth to be extracted periotome held in modified pen grasp and inserted at 20 degrees to the long axis of tooth into the gingival sulcus. It will be used to sever the cervical gingival attachment fibres first and then proceed several millimeters into periodontal ligament space and inclined first mesially and then distally tangential to root surface. Once the access obtained, the instrument will be gradually advanced into the PDL space repeating the same motion until two-thirds of the distance towards the apex of root will be reached. Then tooth will be extracted using extraction forceps exerting rotational force in a coronal direction. Ketorolac tromethamine 10 mg will be given immediately after completion of extraction and 1 Tab SOS later as analgesic. No other postoperative medication will be prescribed. Patients will be instructed not to seek any medical help elsewhere for postoperative problems, if any, but to report to our department. They will be followed-up for a minimum period of 1 week for evaluation of wound.

• All patients will be treated by same surgeon.

• All patients will undergo the standard procedure for single rooted non-surgical removal of tooth.