NCT07310212

Brief Summary

Brief Summary Postoperative pain is a common complication following root canal treatment, particularly in necrotic teeth with asymptomatic apical periodontitis. Although obturation technique has been suggested as a contributing factor to postoperative discomfort, direct clinical comparisons between commonly used methods remain limited. Cold lateral condensation has traditionally been considered the standard obturation technique, while warm vertical obturation systems such as Obtura II have gained popularity due to their potential for improved adaptation of gutta-percha. This randomized controlled clinical trial aims to compare postoperative pain experience and treatment outcomes following cold lateral condensation and warm vertical obturation in single-rooted necrotic teeth. Postoperative pain will be assessed during the early healing period, along with patient-reported outcomes and short-term clinical and radiographic healing. The results of this study are expected to provide clinically relevant evidence to support evidence-based obturation technique selection and improve patient comfort in endodontic practice.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
7mo left

Started Oct 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress73%
Oct 2024Dec 2026

Study Start

First participant enrolled

October 17, 2024

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2025

Completed
4 months until next milestone

First Posted

Study publicly available on registry

December 30, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

April 2, 2026

Status Verified

March 1, 2026

Enrollment Period

1.6 years

First QC Date

August 29, 2025

Last Update Submit

March 27, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Postoperative pain intensity following two different obturation techniques

    Visual Analog Scale (VAS), 0-10 0 represents no pain, 10 represents excruciating pain

    Baseline (6 hours post-treatment), 12 hours post-treatment,1 day, 2 days, 3 days, 4 days, and daily up to 7 days post-treatment

Secondary Outcomes (3)

  • Patient Satisfaction

    Immediately after treatment6 months post treatment

  • Assess the need for pain medication

    6 hours post treatment12 hours post treatment1 day2 days3 days4 days up to the complete resolution of pain

  • Evaluation of diffrence in success rate

    Immediately After treatment 6 months posttreatment

Study Arms (2)

Warm vertical obturation

ACTIVE COMPARATOR
Procedure: Warm Vertical Condensation (WVO)

Cold lateral condensation obturation

EXPERIMENTAL
Procedure: Cold Lateral Condensation (CLC)

Interventions

Following standard endodontic cleaning and shaping with rotary instrumentation and irrigation, canals will be obturated using the warm vertical condensation technique. After placement of a master cone coated with AH Plus sealer, heat is applied to soften and vertically compact the gutta-percha within the canal. The Obtura II system will be used to backfill the canal with thermoplasticized gutta-percha, ensuring three-dimensional adaptation and dense filling of the root canal space.

Warm vertical obturation

Following standard endodontic cleaning and shaping with rotary instrumentation and irrigation, canals will be obturated using the cold lateral condensation technique. A master gutta-percha cone coated with sealer (AH Plus) will be inserted, and accessory cones will be compacted laterally using spreaders until the canal is fully obturated. This technique is widely regarded as the traditional standard method for root canal obturation.

Cold lateral condensation obturation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 18 years or older.
  • Patients requiring endodontic treatment for single-rooted necrotic teeth.
  • Radiographic and clinical diagnosis of asymptomatic apical periodontitis.
  • Ability to understand the study and provide written informed consent.

You may not qualify if:

  • Teeth diagnosed with symptomatic apical periodontitis.
  • Pregnant or lactating women.
  • Patients with systemic diseases affecting pain perception (e.g., uncontrolled diabetes, chronic pain conditions).
  • Teeth that have been previously endodontically treated.
  • Patients taking medications that may influence pain perception (e.g., chronic analgesic or anti-inflammatory drug use).
  • Periodontally compromised teeth with significant bone loss or mobility.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Jordan Hospital

Amman, Amman Governate, 11942, Jordan

RECRUITING

MeSH Terms

Conditions

Dental Pulp Necrosis

Condition Hierarchy (Ancestors)

Dental Pulp DiseasesTooth DiseasesStomatognathic DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Dalin Jihad AlSawaftah, Endodontic resident, DDs

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Endodontic resident

Study Record Dates

First Submitted

August 29, 2025

First Posted

December 30, 2025

Study Start

October 17, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

April 2, 2026

Record last verified: 2026-03

Locations