Evaluation of Postoperative Pain and Success Rate Between Lateral Condensation and Warm Vertical Obturation Techniques - A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Jordan
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Postoperative pain intensity following two different obturation techniques
Study Overview
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.
Detailed Description
This study is a prospective, parallel-group randomized controlled clinical trial designed to investigate the influence of obturation technique on postoperative pain experience and short-term treatment outcomes in single-rooted teeth with necrotic pulps.
All endodontic treatments will be performed by a single experienced operator to minimize inter-operator variability. After administration of local anesthesia and placement of rubber dam isolation, standardized access cavities will be prepared. Working length determination will be performed using an electronic apex locator and confirmed radiographically.
Root canal preparation will be carried out using rotary nickel-titanium instruments according to a standardized instrumentation protocol applied uniformly across all participants. Irrigation will be standardized for all cases and will include sodium hypochlorite during instrumentation and ethylenediaminetetraacetic acid (EDTA) for smear layer removal, followed by final canal irrigation and drying using sterile paper points. All procedural steps prior to obturation will be identical between groups to isolate the effect of obturation technique on postoperative outcomes.
Participants will be randomly assigned to one of two obturation techniques:
- Cold lateral condensation, performed using standardized gutta-percha cones and an epoxy resin-based sealer.
- Warm vertical condensation, performed using a thermoplasticized gutta-percha delivery system (Obtura II) in combination with gutta-percha and the same sealer.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
Warm vertical obturation
Intervention: Warm Vertical Condensation (WVO) (Procedure)
Cold lateral condensation obturation
Intervention: Cold Lateral Condensation (CLC) (Procedure)
Outcomes
Primary Outcomes
Postoperative pain intensity following two different obturation techniques
Time Frame: 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
Visual Analog Scale (VAS), 0-10 0 represents no pain, 10 represents excruciating pain
Secondary Outcomes
- 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)
Investigators
Dalin Al Sawaftah
Endodontic resident
University of Jordan