RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,
BANGALORE, KARNATAKA.
ANNEXURE II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
1. / Name of the CandidateAnd Address (in block letters) /
Dr. SANCHITA GULATI
POSTGRADUATE STUDENT
DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS,BAPUJI DENTAL COLLEGE AND HOSPITAL,
DAVANGERE – 577 004,
KARNATAKA.
2. /
Name of the Institution
/ BAPUJI DENTAL COLLEGE AND HOSPITAL,DAVANGERE – 577 004,
KARNATAKA.
3. / Course of Study
AND SUBJECT / MASTER OF DENTAL SURGERY CONSERVATIVE DENTISTRY AND ENDODONTICS
4. / Date of admission to THE COURSE / 30/05/2012
5. /
Title of the dissertation
/ “AN IN-VIVO RADIOGRAPHIC EVALUATION OF TREATMENT OUTCOME IN CASES WITH CHRONIC APICAL PERIODONTITIS OBTURATED USING COLD LATERAL CONDENSATION IN COMBINATION WITH THREE DIFFERENT SEALERS”6.
7. / BRIEF RESUME OF THE INTENDED WORK:
6.1 Need for the study:
The achievement of a three dimensionally well fitted root canal is one of the goals of endodontic treatment. Key to success is the complete closure of the dentinal wall-obturating core interface to achieve the tight seal.1 In this respect, the role of sealers becomes very significant. An ideal root canal sealer should be biocompatible, inert, provide excellent seal when set, produce adequate adhesion, should be radiopaque, non staining and dimensionally stable. In addition, it should be bactericidal and non irritating to periapical tissue.2
Gutta-percha cones in conjunction with a sealer serves as a protection after biomechanical root canal preparation by preventing bacterial ingress and allowing regenerative processes in the periapical tissues.3 The overfilling of the material predisposes periradicular tissue to epithelial proliferation and impaired repair whereas underfilling can leave a small portion of root canal system available for bacteria to
re –establish.2
Over the years, a number of different sealers have been used in conjunction with gutta percha for root canal obturation. Zinc oxide eugenol sealers have been used since 1930’s.4 Practically all ZOE sealers are cytotoxic and invoke an acute inflammatory response in connective tissues either due to inherent cytotoxicity or due to bacterial degradation products. Evidence suggests that the presence of foreign material in the periapical tissues causes persistence tissue breakdown.5
Epoxy-resin based cements have also presented good performance as root canal sealer. Studies have concluded that these materials are well tolerated by the periapical tissues. Excess material in the periodontal ligament tends to become encapsulated.5 AH Plus has better penetration into the micro irregularities because of its creep capacity and long setting time, which increases the mechanical interlocking between sealer and root dentin.6 It has excellent sealing property without the release of formaldehyde.7 Epoxy resin sealers (AH Plus) have advantages like high radio opacity, low solubility, less shrinkage, better periapical repair, and tissue compatibility.8
It has only been within the past decade that we have witnessed significant changes in endodontic biomaterials. The new Bioceramic Sealer containing calcium silicate, calcium phosphate has been introduced. Advantage of sealer itself is its ability to form hydroxyapatite and to create a bond between dentin and appropriate filling material. Furthermore, the formation of calcium hydroxide as a by-product of the setting reaction (initiated by moisture present in dentinal tubules) produces a very high alkaline pH (12.8) rendering the material antibacterial. This sealer has exceptional dimensional stability and does not shrink upon setting and consequently, is non-resorbable inside root canal. Additionally, the direct application of this premixed, injectable form of bioceramic material into the root canal makes it exceedingly efficient for clinical use and shows significant clinical success.9
It has been shown that Endosequence BC sealer has lower cytotoxicity than AH Plus and Tubliseal.10 Earlier studies have compared the various aspects of endosequence BC sealer but clinical comparative studies are minimal. This study will be an attempt to compare the Radiological outcome of EndoSequence BC or AH Plus as a root canal sealer compared to Zinc Oxide Eugenol using Gutta percha as the obturating material in humans.
6.2 Null Hypothesis:-
There is no difference in treatment outcome of root canals obturated with cold lateral condensation with three different sealers (Zinc oxide eugenol, AH Plus and EndoSequence BC)
6.3 Research Hypothesis:-
There is difference in treatment outcome of root canals obturated with cold lateral condensation with three different sealers (Zinc oxide eugenol, AH Plus and EndoSequence BC)
6.4 Review of literature
. A multicenter, prospective clinical study was conducted to assess the treatment result upto 1 year after endodontic treatment of apical periodontitis using a Silicone based sealer (Roeko seal automix, Roeko, Langenau,Germany) in comparison with a ZOE – based, Grossman’s type sealer. A total of 199 teeth were treated at three centres and sealer was chosen randomly at the time of filling. It was found that average PAI scores decreased from 3.43 to 2.21 at the start of 12 month for Grossman’s sealer and from 3.40 to 2.26 for the silicone based material. No significant difference between the groups at start or any of the follow ups was seen. The 3 – month control was adequate in establishing significant healing in both groups.3
A Study was conducted on evaluation of physicochemical properties of Endosequence BC bioceramic root canal sealer in comparison of AH Plus sealer. Results showed that Endosequence showed PH and calcium ion release greater than that of AH
Plus. Endosequence BC sealer showed radioopacity and flow in accordance with ISO `
recommendations.9
An in vitro study was conducted to evaluate the cytotoxicity of Endosequence BC and Gutta flow sealer and comparison was done with AH Plus and Tubliseal sealer. For the cell toxicity assay, L929 cells were seeded into 96 well plates at 3x104 cells per well and incubated for 24 hours to allow adhesion. Then sealer eluate from the different eluate groups was added to culture wells. After 24-hour incubation period, cell viability was evaluated and results showed that AH Plus sealer had greater cytotoxicity than the other 3 sealers and Tubliseal was more cytotoxic than the BC and Guttaflow sealers.10
A study was conducted to compare the antimicrobial effect and cytoxicity of endosequence BC, AH Plus and Zinc oxide eugenol sealers. Possible antibacterial properties of the different sealers were visualized by means of Scanning Electron Microscope. The results revealed that Endosequence BC showed relatively non-cytotoxic reactions, while AH Plus caused a significant decrease of cell proliferation and Endosequence can be considered as a biocompatible sealing material.11
An In vivo study was conducted to compare the clinical and radiographic treatment outcome of Procosol, CRCS, Sealapex sealers. 204 teeth underwent standardized endodontic treatment regimen and were divided into 3 groups at the time of root filling according to the type of sealer used. Results were assessed yearly up to 4 years by clinical and radiologic (Periapical index scores) controls. The ridit statistic(r) was used to compare PAI scores among groups. During first and second year after filling, the mean ridit value was decreased. By years 3 and 4, no significant difference among the groups was detected.12
6.5 Objectives of the study:
· To evaluate the outcome of root canal treatment using three different sealers.
· To compare the regression or progression of the periapical lesion using three different sealers.
MATERIALS AND METHODS:
7.1 Source of data:
Patients visiting the Outpatient Department of Conservative Dentistry and Endodontics in Bapuji Dental College and Hospital, Davangere, Karnataka, with single rooted teeth indicated for root canal treatment and having radiographic evidence of periapical lesion in the age group of 18-50 years.
7.2 Methods of collection of data
Patient’s written consent will be taken before starting the procedure.
Materials used are:
· Micromotor and air rotor handpiece (NSK)
· Access Preparation kit (Dentsply)
· Hand K-Files (Dentsply)
· Lentulospirals
· Intra-oral radiographs
· X-Ray machine
· Tubliseal root canal sealer(Dentsply)
· AH Plus root canal sealer(Dentsply Detrey)
· EndoSequence BC root canal sealer(Brasseler USA)
· Gutta percha cones (Dentsply)
· VixWin PRO Dental imaging software (Gendex Dental systems)
· Post- endodontic restorative material
Inclusion Criteria
· Single rooted Teeth having chronic apical periodontitis indicated for root canal
treatment with periapical radiolucency that is readily visible in the radiographs3
and having periapical index score > 2
· Single rooted teeth in the age group of 18 to 50 years
· Patients with good systemic health
Exclusion Criteria
· Retreatment cases.
· Pregnant women and lactating mothers.
· Subjects who will be suffering from systemic diseases that contraindicate root canal treatment.
· Fractured teeth, root resorption cases and calcified canals.
· Iatrogenic tooth/root perforation and apical obturating material extrusion during treatment.
· Multiple adjacent teeth having periapical radiolucencies indicated for root canal treatment.
· Immunocompromised patients.3
Sample Size Determination
Based on available information, the required sample size was determined using the formula:-
n = 2t2s2
d2
where t = theoretical value of t distribution at 95% confidence i.e. = 2.13
d = minimum expected difference(change) in the periapical radiolucency
s = pooled standard deviation = 1.5 mm ( from the previous studies)
Level of significance(α)=5%
Power of study=80%
n = 2×(2.13)2×(1.5)2
(1.0)2
= 10.6 (11)
To Balance the drop outs, Adjusted sample size13 was determined using the formula:-
N1 = n
1-d
Where N1 = Adjusted sample size
n = Sample size required as per formula i.e. = 11
d = Dropout rate i.e.30%
By substituting the values:-
N1 = 11
1-0.3
= 15.7
= 16
Thus the sample size planned for study will be 16 in each group.
TREATMENT MODALITY
Prior to treatment, patient’s demographic details and thorough history of presenting illness will be recorded. Clinical evaluation will be performed using visual and tactile examination, percussion, thermal tests, electric pulp testing, periodontal probing and mobility assesment.14
Preoperative radiographic evaluation will be performed with Periapical radiograph15 using paralleling technique16,17 and periapical index score will be recorded.18 A Digital radiograph19 will be taken using RVG apparatus.20
Treatments will be performed using a two-visit technique.
FIRST VISIT:-
· Teeth will be first isolated with rubber dam.
· Cavity will be excavated and if necessary, pre-endodontic management will be done.
· Access cavity preparation will be done using airrotor and access preparation kit.
· A K-File of appropriate size will be introduced in root canal and working length will be verified with Propex-II apex locator.
· Root canals will be instrumented using Hand K-Files21-23 along with intermittent irrigation using 2.5% NaOCl.
· All canals will be prepared 1mm short of radiographic apex using Step-Back Technique.24,25
· At the completion of the preparations, canals will be rinsed with 5ml of 2.5% NaOCl26 followed by final flush with 5 ml of sterile saline.
· Lentulospirals will be coated with Ca(OH)2 as intracanal medicament27,28 and then
introduced into root canal, by rotating in anticlockwise manner.
· Pulp chamber will be closed with cotton pellet and cavit.
· Patients will be recalled after 7 days for further treatment.29
Patients will be informed to report immediately after the first visit, if sudden increase in symptoms like pain and swelling occurs. At this visit, active treatment is rendered that may include incision for drainage, canal debridement and use of intracanal medicament, reducing the occlusion, prescribing appropriate medications30 and patients will be recalled back for root canal obturation with appropriate sealer.
SECOND VISIT:-
· Tooth will be isolated with Rubber dam.
· Temporary restoration will be removed and reaccess will be obtained.
· Intracanal medicament will be removed from the canals using #15 K-File agitated irrigation with 17% EDTA.29,31
· Canals will be irrigated with sterile saline solution.
· Patients will be randomly divided into 3 groups using randomization procedure according to the type of root canal sealer used.
Group 1- Tubliseal root canal sealer along with Gutta Percha
Group 2- AH Plus root canal sealer along with Gutta Percha
Group 3- Endosequence BC root canal sealer along with Gutta Percha
For all the three groups, manufactures instructions will be followed for the manipulation of the root canal sealers and canals will be obturated with cold lateral condensation technique.33,34
Follow-ups will be done after 6 months and again after the period of 9 months and clinical and radiographic periapical status will be examined. At each appointment, radiological outcome with periapical index will be made and Radiological outcome for regression or progression of the lesion will be made by morphometric analysis of immediate postoperative and follow-up digital images using Vix Win (Gendex dental systems) digital image analyzing software.
Statistical Analysis
One way ANOVA will be used for multiple simultaneous comparisons followed by Post-hoc Tukey’s test for pair wise comparison. Intra-group comparisons will be done by
Repeated measures ANOVA.
7.3 Does the study require any investigation or intervention to be conducted on the
Patients or other human or animals? If so, please describe briefly.
YES. Study wll be conducted on patients diagnosed with chronic apical periodontitis, requiring endodontic requirement.
7.4 Has the ethical clearance being obtained from your institution in case of 7.3
YES. Ethical clearance report attached here with
LIST OF REFERENCES
1. Johnson WT, Gutmann JL. Obturation of the cleaned and shaped root canal system In: Cohen S, Hargreaves KM. Pathways of the Pulp. 9th ed. Missouri: Mosby; 2006. p. 358-399
2. Grossman LI, Oliet S, Delrio C. Endodontic Practice 11th ed. Lea and Febiger: Philadelphia; 1988. p. 242-259
3. Huumonen S, lenander-lumikari M, Sigurdsson A, Orstavik D. Healing of apical periodontitis after endodontic treatment: a comparison between a silicone based and a zinc oxide- eugenol- based sealer. Int endod J. 2003;36(4):296-301
4. Sousa Neto MD, Guimaraes LF, Gariba Silva R, Saquy PC, Pecora JD. Influence of different grades of rosins and hydrogenated resins on powder-liquid ratio of Grossman Cements. Braz Dent J. 1998;9(1):11-8
5. Seltzer S. Endodontology- Biologic considerations in endodontic procedures. 2nd ed. Lea and Febiger: Philadelphia; 1988. p. 281-325
6. Nunes VH, Silva RG, Alfredo E, Sousa-Neto MD, Silva-Sousa YT. Adhesion of Epiphany and AH Plus sealers to human root dentin treated with different solutions. Braz Dent J. 2008;19(1): 46-50
7. De Almeida WA, Leonardo MR, Tanomaru Filho M, Silva LA. Evaluation of apical sealing of three endodontic sealers. Int endod J. 2000 Jan;33(1):25-7