An interventional study of Warm Vertical Condensation (WVO) and Cold Lateral Condensation (CLC) in Necrotic Pulp and Asymptomatic Apical Periodontitis, sponsored by University of Jordan. Recruiting at 1 site in Jordan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-02.
Sponsored by University of Jordan · Not applicable, Interventional, and Treatment
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.
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:
Obturation procedures will be conducted according to manufacturer instructions and established clinical guidelines. Immediate coronal sealing will be completed following obturation to reduce the risk of coronal microleakage.
Postoperative pain will be assessed using a Visual Analog Scale (VAS). Participants will receive standardized written and verbal instructions on how to record pain intensity at predefined time points following treatment. Analgesic consumption during the postoperative period will also be documented. Follow-up contact will be made as needed to ensure adherence to pain recording and study protocols.
Clinical and radiographic evaluations will be performed at baseline and at a 6-month follow-up visit to assess treatment outcome and periapical healing. Standardized periapical radiographs will be obtained using consistent exposure parameters. Radiographic assessment will be performed by a blinded assessor to reduce assessment bias.
Randomization will be carried out using sealed opaque envelopes prepared prior to patient recruitment. Due to the nature of the intervention, operator blinding is not feasible; however, patients will be blinded to the obturation technique used, and outcome assessment will be performed by blinded evaluators whenever applicable.
This study is designed to generate controlled clinical evidence regarding the effect of obturation technique on postoperative pain perception and short-term treatment outcomes in necrotic single-rooted teeth, thereby supporting evidence-based clinical decision-making in endodontic practice.
156 studies on the registry are indexed under Dental Pulp Necrosis; 43 are open to participants now.
This study's planned enrollment of 80 is above the median of 45 across 147 interventional studies indexed under Dental Pulp Necrosis.
Browse Dental Pulp Necrosis studies →University of Jordan is the lead sponsor of 131 studies on the registry; 20 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: Warm Vertical Condensation (WVO)
Procedure: Cold Lateral Condensation (CLC)
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.
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.
Postoperative pain intensity following two different obturation techniques
Visual Analog Scale (VAS), 0-10 0 represents no pain, 10 represents excruciating pain
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
Patient Satisfaction
Questionnaire: Extremely satisfied Satisfied Neutral Dissatisfied Extremely dissatisfied The maximum is extremely satisfied The minimum is extremely dissatisfied
Time frame: Immediately after treatment6 months post treatment
Assess the need for pain medication
Yes/no The check wether or not the patient needed painkillers If yes what time 'They were advised to take ibupren 400 mg in case of pain and to record when did they need it''
Time frame: 6 hours post treatment12 hours post treatment1 day2 days3 days4 days up to the complete resolution of pain
Evaluation of diffrence in success rate
Comparing Periapical radiographs
Time frame: Immediately After treatment 6 months posttreatment
Plan to share: Undecided
No publications or documents are linked to this record.
Started Oct 2024 (actual). Primary completion is estimated for Jun 2026, 19 months after the start.
Of 66 non-industry interventional studies with no phase under Dental Pulp Necrosis, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 35. This study's planned 19 months is above that.
Counting every sponsor, half of 67 studies reached it within 15 months; a quarter within 9 and three quarters within 31.
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