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Effect of Smear Layer on Endodontic Outcome

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ClinicalTrials.gov Identifier: NCT03277404
Recruitment Status : Completed
First Posted : September 11, 2017
Last Update Posted : September 11, 2017
Sponsor:
Information provided by (Responsible Party):
Postgraduate Institute of Dental Sciences Rohtak

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Apical Periodontitis Procedure: Root canal treatment with smear layer removal Procedure: Root canal treatment without smear layer removal Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Smear Layer on Endodontic Outcome: A Randomized Controlled Trial
Actual Study Start Date : May 7, 2015
Actual Primary Completion Date : November 30, 2015
Actual Study Completion Date : November 30, 2015

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 Name: 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 Name: irrigation with EDTA




Primary Outcome Measures :
  1. Radiographic success [ Time Frame: every 3 months till 12 month period ]
    Size of apical radiolucency were scored according to PAI scores and PAI score less than 3 were considered as success

  2. Clinical success [ Time Frame: till 12 months ]
    Presence or absence of any clinical symptoms such as pain,tenderness, sinus tract and swelling


Secondary Outcome Measures :
  1. Pain intensity [ Time Frame: Patients were asked to make a mark on the line that represented their level of perceived pain every 24hrs for7 days following intervention ]
    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.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Responsible Party: Postgraduate Institute of Dental Sciences Rohtak
ClinicalTrials.gov Identifier: NCT03277404    
Other Study ID Numbers: Jyoti Rana
First Posted: September 11, 2017    Key Record Dates
Last Update Posted: September 11, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Postgraduate Institute of Dental Sciences Rohtak:
EDTA
Postoperative pain
Pulp necrosis
Smear layer
Additional relevant MeSH terms:
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Periodontitis
Periapical Periodontitis
Smear Layer
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Periapical Diseases
Jaw Diseases
Dental Deposits
Tooth Diseases