Comparing Different Single and Combination Chelating Agents on Sealer Penetration and Dentin Erosion.

NCT05778227 | Completed DMC

• 1 other identifier: szubair
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Root Canal Infection; Periapical Abscess; Irreversible Pulpitis; Apical Periodontitis

Outcome Measures

Primary Outcomes (2)

• Sealer penetration

  Samples were studied for dentinal tubule penetration by Scanning electron microscope (SEM) .They were evaluated at three levels coronal, middle and apical third by blinded independent observer. For each sample image, maximum linear depth of sealer penetration was measured in micrometers circumferentially at four locations (buccal, lingual, mesial and distal) . After recording four circumferential readings, final mean sealer penetration was calculated for each sample in micrometers

  4 months

• Dentin erosion

  The erosion in the coronal, middle and apical third of the root canal walls were measured by scanning electron microscope (SEM). Photomicrogrpahs were scored by two independent investigators who were unaware of the groups using the scale suggested by Torabinejad et al score 1: No erosion, all tubules exhibited a normal appearance and size. Score 2: Moderate erosion, the peritubular dentin was eroded. Score 3: Severe erosion, the intertubular dentine was destroyed and the tubules were connected to each other. Chemical characterization (mass %) was performed by Energy Dispersive Xray spectroscopy (EDX).. All samples were then subjected to EDX analysis to determine total calcium (Ca) and phosphorus (P) content and the alteration in Ca/ P ratio on the root third of each group. The mineral content was not determined before the treatment of each sample because this analysis requires a destructive method. Thus, it is likely that the mineral content differed between all teeth

  2 months

Study Arms (5)

Ethylene Diamine Tetra Acetic acid

ACTIVE COMPARATOR

Final irrigation will be done with 5ml of EDTA for 1min which is the gold standard and compare it with experimental irrigants.

Drug: Ethylene Diamine Tetra Acetic acid

smearOFF

EXPERIMENTAL

Final irrigation will be done with 5ml of EDTA for 1min which is the gold standard and compare it with experimental irrigants.

Drug: smearOFF

Etidronic acid/ Sodium Hypochlorite (HEBP/NaOCl)

EXPERIMENTAL

During whole procedure of cleaning and shaping combination product of HEBP/NaOCl will be used

Drug: Etidronic acid /sodium hypochlorite

Maleic acid (MA)

EXPERIMENTAL

Final irrigation of root canal treatment procedure will be done with 5ml of maleic acid for 1min.

Drug: Maleic acid

Control group

NO INTERVENTION

Final irrigation of root canal treatment will be done with 0.9% saline.

Interventions

Ethylene Diamine Tetra Acetic acid DRUG

Final irrigation will be done with 5ml of EDTA for 1min which is the gold standard and compare it with experimental irrigants.

Also known as: EDTA

Ethylene Diamine Tetra Acetic acid

smearOFF DRUG

Final irrigation of root canal treatment procedure will be done with 5ml of smearOFF for 1min.

Also known as: SOFF

smearOFF

Etidronic acid /sodium hypochlorite DRUG

During whole procedure of cleaning and shaping combination product of HEBP/NaOCl will be used

Also known as: HEBP/NaOCl

Etidronic acid/ Sodium Hypochlorite (HEBP/NaOCl)

Maleic acid DRUG

Final irrigation of root canal treatment procedure will be done with 5ml of maleic acid for 1min.

Also known as: MA

Maleic acid (MA)

Eligibility Criteria

• Age: 17 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Permanent single rooted premolars with single canal.
• Sound teeth with mature apices.
• Teeth extracted for orthodontic purpose.
• Age between 17 -25 years (male or female)

You may not qualify if:

• Intracanal calcification or pulp stones.
• Root dilacerations and developmental defects. 3 Caries, fracture or cracked teeth.
• \. Previously endodontically treated teeth or restorations. 5. Root resorption.

Sponsors & Collaborators

• Dow University of Health Sciences: lead

Study Sites (1)

Dow University of Health Sciences

Karachi, Sindh, 74000, Pakistan

Location

MeSH Terms

Conditions

Periapical Abscess; Periapical Periodontitis

Interventions

Edetic Acid; Etidronic Acid; Sodium Hypochlorite; maleic acid

Condition Hierarchy (Ancestors)

Abscess; Suppuration; Infections; Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis

Intervention Hierarchy (Ancestors)

Ethylenediamines; Diamines; Polyamines; Amines; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Diphosphonates; Organophosphonates; Organophosphorus Compounds; Hypochlorous Acid; Chlorine Compounds; Inorganic Chemicals; Oxides; Oxygen Compounds; Sodium Compounds

Study Officials

• Sehrish Zubair

  Dow University of Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: In this study the participants are coded and the outcome assessor is blinded
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Four group assigned with interventions and one control group.

Study Record Dates

• First Submitted: January 22, 2023
• First Posted: March 21, 2023
• Study Start: November 16, 2021
• Primary Completion: May 15, 2023
• Study Completion: August 20, 2023
• Last Updated: October 26, 2023

Record last verified: 2023-10

Locations

PA (1)