RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES
BANGALORE, KARNATAKA.
ANNEXURE –II
PROFORMA FOR REGISTRATION
OF
TOPIC OF DISSERTATION.
1 / Name of candidate and address (in block letters) / Dr.HRISHIKESH A SAOJI.VYDEHI INSTITUTE OF DENTALSCIENCES AND RESEARCH CENTRE,
#82,EPIP AREA,NALLURAHALLI, WHITE FIELD, Bangalore-560066.
2 / Name of institution / VYDEHI INSTITUTE OF DENTALSCIENCES AND
RESEARCH CENTRE, BANGALORE.
3 / Course of study and subject / MASTER OF DENTAL SURGERY,
CONSERVATIVE DENTISTRY AND ENDODONTICS.
4 / Date of admission to course / 25th May 2011
5 / Title of topic / In vivo comparative evaluation of three intraligamentary anaesthetic delivery systems during restorative procedures.
6 BRIEF RESUME OF INTENDED WORK
6.1 NEED FOR THE STUDY
Many clinicians have described difficulties related to intraligamentary injections including positioning of needle in the desired locations, controlling placement of needle throughout the administration of anaesthesia, increased pain perception reported by dental patients due to high syringe pressure and consequent tissue damage.
Other concerns centre around appropriate amount of anaesthesia to be delivered, duration of effect of anaesthesia and type of anaesthetic that can be injected.
Purpose of this study is to evaluate intraligamentary injection delivered with (a) Computer controlled anaesthetic delivery system,(b) Standard self aspirating syringe, (c)Normal disposable 2cc syringe, for effect of duration of anaesthesia & discomfort during and after the injection in patients requiring restorative treatment.
6.2 Review of Literature:
v An investigation was done by Ferrari et al, to evaluate the efficacy of STATM intraligamentary injection compared with intraligamentary anaesthesia administrated with Ligmaject and dental syringes. The result showed that the STA system resulted in more predictable, reliable and comfortable anaesthesia than the two other tested methods¹.
v A Study was done by Dr. Gibson et al, to evaluate efficacy of computerized anaesthetic delivery system (e.g. wand ) compared to traditional administration with respect to reducing disruptive pain related behaviour during injection.Result showed that the wand can deliver proper anaesthesia and significantly reducing disruptive behaviour during initial movement of injection2
v The study was done by Nussteian et al, a prospective randomized, blind study was done to compare pain of injection & post-injection pain of anterior middle superior alveolar injection using computer assisted wand plus injection system versus conventional syringe. Result showed that the 38% patients had pain on needle insertion with computer assisted injection system and 32% for conventional syringe.3
v A study was done by Berline et al, a prospective randomized double blind study was done to compare anaesthetic efficacy of intraligamentary injection of 4% articaine with 1:1,00,000 epinephrine and 2% lidocaine with 1:1,00,000 epinephrine administrated with computer controlled anaesthetic delivery system in mandibular posterior teeth. Result showed that the efficacy of 4% articaine with 1:1,00,000epinephrine was similar to the efficacy of 2% lidocaine with 1:1,00,000 epinephrine for intraligamentary injections4.
v E.G.Grace et al conducted study an Computer controlled dental anaesthetic delivery system with the objective of evaluating and comparing unit to traditional method of anaesthetic delivery. Result showed that the computer controlled dental anaesthetic injection and traditional anaesthetic injection system were accepted equally by both dentists and patients5.
6.3 Objective of study:
Objective of this study is to compare efficacy of the intraligamentary injection delivered with (a) computer controlled anaesthetic delivery system,(b) Standard self aspirating syringe, (c)Normal disposable 2cc syringe, with respect to the duration of anaesthesia & discomfort during and after the injection in patients requiring restorative treatment.
7 Materials and Methods:
7.1 Source of data:
Type of study- comparative study.(in vivo)
Study area: Vydehi institute of Dental sciences and Research centre, Bangalore.
Study population: 60 patients will be selected from the Department of Conservative Dentistry and Endodontics from Vydehi institute of dental sciences and research centre, Bangalore.
7.2 Method of data collection:
All patients will be given written informed consent after being informed about all procedures and possible discomfort.
Sample size:
Total number of 60 patients both male and female in age group of 20-40yr
taken for study. These 60 individuals will be randomly divided in to three groups:
Group1(n=20) / Patient receiving anaesthesia with computer controlled anaesthetic delivery system.
Group2(n=20) / Patient receiving anaesthesia with standard self aspirating syringe
Group3(n=20) / Patient receiving anaesthesia with normal disposable 2cc syringe.
Criteria for selection of subjects:
Inclusion criteria:
a. Patients in need of restorative treatment on vital lower molar teeth.
b. Patients between 20-40 years of age.
c. Periodontally healthy teeth.
d. Patients who have had a complete physical examination in the past 12 months; present with good health and with no contraindication to local anaesthesia.
Exclusion criteria:
a. Patients with non-vital teeth.
b. Periodontally compromised teeth.
c. Pregnant females.
d. Patients with neurogenic disorders.
e. Patients who are taking medication that would alter pain perception.
f. Individuals with a history of previous infarction events, history of percutaneous coronary revascularization within the preceding 6 months.
MATERIALS:
1. Computer controlled anaesthetic delivery system.
2. Standard self aspirating syringe.
3. Forty 1.8cc cartridges of 2% lidocaine with 1:80,000 adrenaline.
4. Twenty disposable 2cc syringes.
5. Vial of 2% lignocaine with 1:80,000 adrenaline.
6. 27 gauge needle for computer control system, standard self aspirating syringe, and 2cc disposable syringe.
Data Collection methodology:
Patients will be randomly divided into three groups of twenty teeth each according to their therapeutic needs.(group1, group2, group3)Patients in each group will receive intraligamentary anaesthesia using one of the three different systems as described above.
Injection will be performed using 2% lignocaine with 1:80,000 adrenaline.
0.2ml of solution per root will be deposited into periodontal ligament through the buccal and lingual gingival sulcus.
Counter balanced chart is made for right and left injection sides of each subject. The type of injection and the number of subjects who experienced anaesthetic success will be recorded.
All patients will receive restorative treatment according to their treatment plan.
Comfort- Discomfort during injection
Clinical evaluation will be done in each patient before commencement to evaluate whether sensitivity was already present.
A preordered visual analogue scale (from 0 to 10;0=no pain/sensitivity;1-3=low pain;4-6=medium pain; 7-9=high pain; 10=extremely high pain) will be used to account for intraligamentary injection causing different degrees of pain during injection.
Patient will be recalled after 24 hours, to be interviewed and local examination will done if patient had post operative discomfort at injection site and pain during chewing.
Duration of anaesthesia will be evaluated after 1minute, 10minutes, 20minutes, 30minutes and 40minutes, and if any additional injection is required will be recorded.
Duration of anaesthesia will be evaluated with an electric pulp tester and evaluation consisting of presence or lack of sensitivity will be recorded.
Statistical analysis:
Data will be analysed using - Cox regression analysis.
- Chi-square test.
7.3 Does the study require any investigation to conduct on patients or human or animals? If so please describe briefly.
Patch test for hypersensitivity will be done on every patient before administration of injection.
Pilot study had been done on patients after getting written consent from patients and ethical clearance from the institutional ethical committee.
7.4 Has ethical clearance been obtained from your institution in case of 7.3?
YES
8 LIST OF REFERENCES:
1. Ferrari M, Cagidiaco M C , Ferrari et al: Efficacy of computer- controlled injection system STATM, the Ligmajet, and the dental syringe for intraligamentary anaesthesia in restorative patients. INTERNATIONAL DENTISTRY SA2006;11(1):4-12.
2. Gibson R S., Allen K , et al: The Wand vs. Traditional injection: A comparison of pain related behaviours. Pedistr dent 2000;22:458-62
3. Nusstein J, Lees, Nusstein et al: Injection pain and post injection pain of anterior middle superior alveolar injection administrated with the Wand or conventional syringe .Oral Surg Oral Med Oral pathol Oral Radiol Endod 2004;98:124-31.
4. Berlin J, Nusstein J, Berlin et al: Efficacy of articaine and lidocaine in a primary intraligamentary injection administrated with computer controlled anaesthetic delivery system. Oral surg Oral Med Oral Pathol Oral Radiol Endod 2005;99:361-6.
5. Grace E.G., Barnes D.M., et al:Computerized local dental anaesthetic system: patient and dentist satisfaction. Journal of dentistry 2003;31:9-12
9 / Signature of candidate / (DR. HRISHIKESH A. SAOJI.)
10 / Remark of guide / The synopsis of this dissertation titled “In vivo comparative evaluation of three intraligamentary anaesthetic delivery systems during restorative procedures.” is prepared as per the specification of RGUHS and is verified and found to be acceptable by me.
11 / Name and designation
(in block letters)
11.1 Guide / DR.MOHAN THOMAS NAINAN. PROFESSOR AND HEAD DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS. VYDEHI INSTITUTE OF DENTAL SCIENCES AND RESEARCH CENTRE, BANGALORE.
11.2 Signature
11.3 Head of the department / DR.MOHAN THOMAS NAINAN. PROFESSOR AND HEAD DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS. VYDEHI INSTITUTE OF DENTAL SCIENCES AND RESEARCH CENTRE, BANGALORE.
11.4 signature
12 / 12.1 Remark of the chairman and principle.
12.2signature