Effect of Smear Layer on Endodontic Outcome

Effect of Smear Layer on Endodontic Outcome: A Randomized Controlled Trial

This study evaluated the effect of removal of smear layer on the success of primary root canal treatment.Patients requiring primary root canal treatment in mature mandibular first and second molars were allocated to either smear layer positive group and smear layer negative group.

Study Overview

• Status: Completed
• Conditions: Apical Periodontitis
• Intervention / Treatment: Procedure: Root canal treatment without smear layer removal; Procedure: Root canal treatment with smear layer removal

Detailed Description

Patients requiring primary root canal treatment following the diagnosis of pulp necrosis in permanent mandibular first and second molars having radiographic evidence of periapical radiolucency (minimum size ≥ 2.0 × 2.0 mm) were included in the study. All patients were over 18 years of age and diagnosis of pulpal necrosis was confirmed by negative response to cold and electrical tests, and absence of bleeding on entering the pulp chamber. Patients with systemic illness, history of analgesic intake within past 7 days, antibiotics in the last 3months and patients who were pregnant were excluded from the study. Periodontally compromised teeth, previously accessed teeth, teeth that were not suitable for rubber dam isolation were also excluded from the study.

Subjects were allocated to one of the two study groups: smear layer positive group (only 2.5%NaOCl was used) - SP and smear layer negative group (17% EDTA+2.5%NaOCl was used) - SN. Using an equal proportion randomization allocation ratio, patients were assigned to the two groups using envelopes containing concealed assignment codes. It was ensured that neither the patient, nor the primary investigator was aware of the group till the time of final rinse.

After administration of local anesthesia, rubber dam isolation of the involved tooth was done. Caries was excavated and access cavity prepared using carbide burs in high speed handpiece with copious irrigation.Debridement of the pulp chamber was done and all canal orifices identified.Working length was obtained with the help of electronic apex locator and confirmed radiographically.Hand files number 10, 15 and 20 were used till working length (WL) to prepare a smooth reproducible glide path.Canal preparation was done with the help of rotary NiTi files. In both groups, 2.5% sodium hypochlorite was used as irrigant after each instrument. All the irrigation procedures were performed using a 27 gauge side vented needle. After root canal instrumentation, 17% Ethylenediaminetetraacetic acid (EDTA) solution was also used to remove smear layer in smear layer negative group, while teeth in smear layer positive group was simply rinsed with 2.5% sodium hypochlorite. In both the groups ultrasonic activation of irrigant was done. An inter-appointment dressing of calcium hydroxide was given. The access cavity was then restored with intermediate restorative material (Dental Products of India).

Patients were prescribed Ibuprofen 400mg with the instructions to take one tablet every 8 hours in the event of pain.Patients were asked to record the severity of pain using 10 cm VAS scale with 0 depicting no pain and 10 depicting maximum pain imaginable. Patients were asked to make a mark on the line that represented their level of perceived pain every 24hrs for 7 days following intervention.

One week later, patients returned with the completed questionnaires.

At the same appointment the intracanal dressing was removed with H-files and copious irrigation with 2.5% NaOCl in both the groups.

17% EDTA solution was used to remove smear layer in smear layer negative group, followed by 2.5% NaOCl while teeth in smear layer positive group were simply rinsed with 2.5% sodium hypochlorite.

Ultrasonic activation of irrigant was done and canals were obturated with the GuttaPercha and Zinc Oxide-Eugenol based sealer in both the groups. After obturation, the cavity was restored permanently.Immediate post-operative radiograph was then taken using preset exposure parameters.Follow up clinical and radiographic examination was carried out every 3 months, till a 12 month period. The data gathered was analyzed using suitable statistical methods.

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Mature permanent mandibular first and second molars requiring primary root canal treatment
• Diagnosis of pulpal necrosis, as confirmed by negative response to cold and electrical tests; and absence of bleeding on entering the pulp chamber
• Radiographic evidence of periapical radiolucency (minimum size ≥ 2.0 × 2.0 mm)
• Patient's age more than 18 years

Exclusion Criteria:

• Patients who do not provide consent for participation in the study
• Age <18 years
• Positive history of antibiotic use within past one month of the treatment
• Patients who are pregnant, diabetic, immunocompromised, had serious medical illness or required antibiotic premedication
• Patients with pockets ≥4mm or having marginal or furcal bone loss due to periodontitis
• Teeth that are not suitable for rubber dam isolation
• Previously accessed teeth and/or with procedural errors
• Unrestorable tooth, fractured/ perforated roots, inflammatory root resorption

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Smear Layer Positive; Root canal treatment without smear layer removal: Root canal treatment and Irrigation with 1 ml of 2.5% sodium' hypochlorite for 1 min, followed by ultrasonic activation of 3 ml of 2.5% sodium hypochlorite for 1minute.	Procedure: Root canal treatment without smear layer removal; only sodium hypochlorite was used for irrigation; Other Names: irrigation with only NAOCL
Active Comparator: Smear layer negative; root canal treatment with smear layer removal:Root canal treatment and Irrigation with 1 mL of 17% EDTA solution and ultrasonic activation, followed by ultrasonic activation of 3 ml of 2.5% sodium hypochlorite for 1 minute.	Procedure: Root canal treatment with smear layer removal; Canal were irrigated with Naocl and EDTA to remove smear layer; Other Names: irrigation with EDTA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic success	Size of apical radiolucency were scored according to PAI scores and PAI score less than 3 were considered as success	every 3 months till 12 month period
Clinical success	Presence or absence of any clinical symptoms such as pain,tenderness, sinus tract and swelling	till 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity	Pain intensity before and after treatment. Intensity of pain was recorded using 10 cm VAS scale with 0 depicting no pain and 10 depicting maximum pain imaginable.	Patients were asked to make a mark on the line that represented their level of perceived pain every 24hrs for7 days following intervention

Collaborators and Investigators

• Sponsor: Postgraduate Institute of Dental Sciences Rohtak

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2015
• Primary Completion (Actual): November 30, 2015
• Study Completion (Actual): November 30, 2015

Study Registration Dates

• First Submitted: June 25, 2017
• First Submitted That Met QC Criteria: September 7, 2017
• First Posted (Actual): September 11, 2017

Study Record Updates

• Last Update Posted (Actual): September 11, 2017
• Last Update Submitted That Met QC Criteria: September 7, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Postoperative pain; EDTA; Pulp necrosis; Smear layer
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Tooth Diseases; Jaw Diseases; Periapical Diseases; Dental Deposits; Periodontitis; Periapical Periodontitis; Smear Layer
• Other Study ID Numbers: Jyoti Rana

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No