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
|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|
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 (Clinical Trial)|
|Actual Enrollment :||86 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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|
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
- 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
- Clinical success [ Time Frame: till 12 months ]Presence or absence of any clinical symptoms such as pain,tenderness, sinus tract and swelling
- 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.