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Apical PeriodontitisNCT03277404

Effect of Smear Layer on Endodontic Outcome

A study testing Root canal treatment with smear layer removal and Root canal treatment without smear layer removal in people with Apical Periodontitis, run by Postgraduate Institute of Dental Sciences Rohtak.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Apical Periodontitis
What is being tested?
Root canal treatment with smear layer removal and Root canal treatment without smear layer removal
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
86 participants
Where
No sites listed yet
Study dates
7 May 2015to 30 Nov 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

About this study

Official title: 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.

Read the 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.

Being tested
Root canal treatment with smear layer removal, Root canal treatment without smear layer removal
Keywords
EDTA, Postoperative pain, Pulp necrosis, Smear layer
Medical subject headings
Periapical Periodontitis, Pain, Postoperative, Dental Pulp Necrosis, Smear Layer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Root canal treatment with smear layer removalProcedure or surgery

    Also called irrigation with EDTA

    Canal were irrigated with Naocl and EDTA to remove smear layer

  • Root canal treatment without smear layer removalProcedure or surgery

    Also called irrigation with only NAOCL

    only sodium hypochlorite was used for irrigation

Study groups in NCT03277404
Study groupRoleWhat they receive
Smear Layer PositiveExperimentalRoot 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.
Receives: Procedure: Root canal treatment without smear layer removal
Smear layer negativeActive comparatorroot 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.
Receives: Procedure: Root canal treatment with smear layer removal

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Radiographic success

    Size of apical radiolucency were scored according to PAI scores and PAI score less than 3 were considered as success

    Measured: every 3 months till 12 month period

  2. Clinical success

    Presence or absence of any clinical symptoms such as pain,tenderness, sinus tract and swelling

    Measured: till 12 months

Secondary outcomes (1)
  1. 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.

    Measured: Patients were asked to make a mark on the line that represented their level of perceived pain every 24hrs for7 days following intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2017
  2. Study start7 May 2015
  3. Primary completion30 Nov 2015
  4. Study completion30 Nov 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
86 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03277404
Sponsor's protocol ID
Jyoti Rana
Status last verified
Jun 2017
First submitted
25 Jun 2017
Last updated
11 Sep 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Root canal treatment with smear layer removal and Root canal treatment without smear layer removal in people with Apical Periodontitis, run by Postgraduate Institute of Dental Sciences Rohtak.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Radiographic success (time frame: every 3 months till 12 month period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2017.

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