Clinical trial

Comparing the Dentin Conditioning Effect of Different Single and Combination Chelating Agents on Sealer Penetration and Dentin Erosion

Name
szubair
Description
The basic aim of root canal treatment is to reduce the microbial content and prevent further recontamination in the canal. Every tooth has a variable, complex canal anatomy consisting of ramifications, accessory and lateral canals. Instrumentation alone cannot reach all the areas for cleaning.The objectives of this research study is to observe and compare the effect of irrigation with smearOFF , etidronic acid/ hypochlorite and other irrigants on sealer penetration and dentin erosion of root dentin by using scanning electron microscope (SEM) and Energy Dispersive X-Ray Analysis (EDX). Hundred extracted premolar teeth is subjected to root canal instrumentation. The endodontic procedure is done with protaper gold files. Initial irrigation is done by 5% sodium hypochlorite. Samples are divided into five groups. Each group consists of twenty single rooted premolars based on final irrigation regimen. There will be four experimental groups which are as follows (1) 17% EDTA (2) SmearOFF 3) Maleic acid (4) HEBP/NaOCL. Whereas, saline will be the control group. After the preparation and final irrigation of all teeth with experimental irrigants, sterile saline is used to flush all canals and dried using paper points. After final irrigation teeth are further divided into two groups (A) Sealer penetration (B) Dentin erosion. In both the groups standardization of root length, cleaning and shaping procedure are the same. For sealer penetration, obturation is done by warm vertical using AH plus sealer. Samples are incubated at 37º Celsius (°C) and 100% humidity for 7 days. The samples are marked and divided into three horizontal section at 2mm, 5mm and 8mm. Using SEM, measure the maximum depth of sealer penetration on each side that is buccal, lingual, mesial and distal and take the mean for each section of sample. For dentin erosion (B) samples are divided sagitally \& buccolingually into two halves. The half containing the most visible part of apical area is taken and than examined using EDX. One-Way ANOVA-test will be used to compare mean values of multiple groups. Tukey's post hoc test will be used to determine the group with significance at P≤0.05. Two observers will evaluate the results using kappa statistics.
Trial arms
Trial start
2021-11-16
Estimated PCD
2023-05-15
Trial end
2023-08-20
Status
Completed
Treatment
Ethylene Diamine Tetra Acetic acid
Final irrigation will be done with 5ml of EDTA for 1min which is the gold standard and compare it with experimental irrigants.
Arms:
Ethylene Diamine Tetra Acetic acid
Other names:
EDTA
smearOFF
Final irrigation of root canal treatment procedure will be done with 5ml of smearOFF for 1min.
Arms:
smearOFF
Other names:
SOFF
Etidronic acid /sodium hypochlorite
During whole procedure of cleaning and shaping combination product of HEBP/NaOCl will be used
Arms:
Etidronic acid/ Sodium Hypochlorite (HEBP/NaOCl)
Other names:
HEBP/NaOCl
Maleic acid
Final irrigation of root canal treatment procedure will be done with 5ml of maleic acid for 1min.
Arms:
Maleic acid (MA)
Other names:
MA
Size
100
Primary endpoint
Sealer penetration
4 months
Dentin erosion
2 months
Eligibility criteria
Inclusion Criteria: 1. Permanent single rooted premolars with single canal. 2. Sound teeth with mature apices. 3. Teeth extracted for orthodontic purpose. 4. Age between 17 -25 years (male or female) Exclusion Criteria: 1. Intracanal calcification or pulp stones. 2. Root dilacerations and developmental defects. 3 Caries, fracture or cracked teeth. 4. Previously endodontically treated teeth or restorations. 5. Root resorption.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Four group assigned with interventions and one control group.', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'In this study the participants are coded and the outcome assessor is blinded', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 100, 'type': 'ACTUAL'}}
Updated at
2023-10-26

1 organization

4 products

4 indications

Indication
Pulpitis
Product
smearOFF