Effect of different medicine to be placed inside the tooth canal, on the pain after root canal treatment in diabetic and non-diabetic patients
- Conditions
- Human volunteers with amandibular molar teeth that were diagnosed with Necrotized Apical periodontitisDiabetes mellitus,
- Registration Number
- CTRI/2020/02/023370
- Lead Sponsor
- Manav Rachna Dental college
- Brief Summary
**INTRODUCTION**
**Postoperative pain is defined as pain of any degree after initiation of endodontic treatment either intra-appointment or post-obturation and is considered an undesirable occurrence for both patient and dentist. Diabetes mellitus(DM) is a complex metabolic disease, characterized by hyperglycemia resulting from defects in insulin secretion, insulin action or both. In patients with DM, several aspects of the immune system are compromised and wound healing is impaired.**
**Studies indicate that diabetic patients have increased prevalence of severe periapical lesions and a decreased success rate of endodontic treatment, suggests that periapical lesions can be modified by diabetes. “During an inflammatory response, leukocytes adhere to endothelial cells due to the presence of adhesion receptors on leukocytes and endothelial cells. The leukocytes eventually become firmly attached to the vascular wall before migrating into tissues. Accordingly, one possible explanation for the abnormal leukocyte function in DM might be a down regulation of adhesion molecules leading to decreased leukocyte– endothelial cell interactions and a reduced number of leukocytes in inflammatory lesions.â€[7]****It was suggested that major cause of postoperative pain is bacterial injury in endodontics. After instrumentation and irrigation Intra-canal medicaments are widely used to kill any bacteria surviving. It is reported that incidence of flare-up are more in patients with diabetes mellitus due to severe endodontic infections.**[**[8]**](http://www.jcd.org.in/article.asp?issn=0972-0707;year=2014;volume=17;issue=3;spage=208;epage=211;aulast=Pai#ref3)**This is attributed to alterations in immune functions and the presence of more virulent microorganisms in root canals of diabetic patients.**Calcium hydroxide is most commonly used medicament throughout the world. It has pain preventive properties because of its antimicrobial property and tissue repair effect.**Purpose of this study is to compare postoperative pain in diabetic and non diabetic patient during root canal treatment with medicament and without medicament.**
**AIM AND OBJECTIVES**
**AIM:**
to compare post operative pain in diabetic and non- diabetic patient during root canal treatment with and without ca(oh)2 in cases of necrosis with symptomatic apical periodontitis
**OBJECTIVE:**
1) To evaluate pain in diabetic patients undergoing root canal treatment with Ca(OH)2
2) To evaluate pain in diabetic patients undergoing root canal treatment without Ca(OH)2
3) To evaluate pain in Non-diabetic patients undergoing root canal treatment with Ca(OH)2
4) To evaluate pain in Non-diabetic patients undergoing root canal treatment without Ca(OH)2
5) To compare pain perception in diabetic and Non-diabetic patient
A. STUDY DESIGN:Interventional Study (Randomised Control Trial)B. **STUDY SUBJECTS:**
· 96 patients
**SAMPLE SELECTION**
Patients with Necrotized Apical periodontitis on mandibular first reporting to Department of Conservative Dentistry & Endodontics at Manav Rachna Dental College, Faridabad will be selected and Informed Consent will be taken.
- SAMPLE SIZE- 96
- At least 24 patients in each group are required with Alpha, beta errors of 0.05 and 0.20, and power of study will be 80%
**INCLUSION CRITERIA**
• 1) Mandibular molar teeth that were diagnosed with Necrotized Apical periodontitis
• 2) Teeth with mature apices
• 3) Patients with age less than 60 yrs
**EXCLUSION CRITERIA**
• 1) Patients who had taken analgesics or anti-inflammatory drugs within the last 12 hours.
• 2)Teeth with calcified canals.
• 3)Pregnant or lactating patients
• 4) Patients with history of allergy to any of the components of local anesthesia
• 5) Teeth with previous RCT
• 6) Teeth with severe damage
**METHODOLOGY**
N=96
(permanent mandibular posterior teeth with mature apices)Pulp sensibility test will be done with the help of EPT and cold test
Patient will be diagnosed in the opd wether he/she is diabetic or non-diabetic by Random Blood Sugar test (> 200 mg/dl) by glucometer
Confirmatory test for diabeties will be done by fasting blood sugar (> 126 mg/dl) and HbA1C test
(1) Non-diabetic = < 5.4 ( 2) Pre-diabetic = 5.4 - 6.7 (3) Diabetic = > 6.7
Four groups – Two group of diabetic and Two group of Non-diabetic
Patients will be asked to complete the Heft parker scale before giving LA
Tooth will be anaesthetized with local anesthesia 2% lidocaine with 1:80,000
Tooth will be isolated with Rubber Dam and disinfection of surrounding areas will be established
After relieving occlusion access opening will be performed , patency of canal will be checked with #10K file.
Working length will be measured by apex locater and checked by radiograph. Cleaning &shaping of the canal will be done using Niti Rotary files. Copious irrigation with 2ml , 3% NaOCl will be used between the instrumentation.
3ml 17% EDTA used to remove smear layer 1 min
copious irrigation with 3% NaOCL will be done
canal will be flushed with 5ml normal saline
after final irrigation, canal will be dried and medicament placement will be done The patients randomly divided into 4 groups. Randomization to be done using online randomization generator(www.randomization.com)
**GROUPING**
GROUP -A GROUP- B GROUP-C GROUP- D
**GROUP A**- Non-Diabetic patient with necrotized apical periodontitis
-Calcium hydroxide will be used as an intracanal medicament
**GROUP B**- Diabetic patient with necrotized apical periodontitis
- Calcium hydroxide will be used as intracanal medicament
**GROUP C-** Diabetic patient with necrotized apical periodontitis
- No intra canal medicament used
**GROUP D-**Non**-**Diabetic patient with necrotized apical periodontitis
- No intracanal medicament used
CALCIUM HYDROXIDE PREAPARATION
Paste will be formed by mixing 1gm of Ca(oh)2 with 1.5 ml of distilled water. Calcium hydroxide is placed as medicament in two groups with help of lentiluspiral
Tooth will be temporized and patient will be recalled after 1 week
Post-operative pain will be evaluated after 6, 24, 48, 72 hours and consecutively for 4 more
days with the help of heft parker scale.
.
After one week canals will be obturated using cold lateral compaction technique with gutta percha and AH Plus sealer.
**STATISTICAL ANALYSIS**
The data will be statistically analyzed using suitable statistical test such as ANOVA test or Kruskal / wallis test
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 96
a)Mandibular posterior teeth with necrosis and symptomatic Apical periodontitis b) Teeth with mature apices less than 60yrs.
- a) Patients who had taken analgesics or anti-inflammatory drugs within the last 6 hours.
- b) Teeth with calcified canals.
- c)Pregnant or lactating patients d)Teeth with previous RCT e)Patients with history of allergy to any of the components of LA.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Post-operative pain Post-operative pain will be evaluated after 6, 24, 48, 72 hours and consecutively for 4 more | days with the help of heft parker scale
- Secondary Outcome Measures
Name Time Method No secondary outcomes No secondary outcomes
Trial Locations
- Locations (1)
Manav Rachna Dental college,
🇮🇳Faridabad, HARYANA, India
Manav Rachna Dental college,🇮🇳Faridabad, HARYANA, IndiaAlka GurawaPrincipal investigator08527064334alkagurawa@gmail.com