An interventional study of Bioceramic Sealer and Warm Vertical Compaction in Apical Periodontitis and Periapical Lesion, sponsored by Medipol University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-08-06.
Sponsored by Medipol University · Not applicable, Interventional, and Treatment
The aim of this clinical study is to evaluate the effect of root canal filling, which is the last stage of root canal treatment (RCT), on the post-operative pain level on single rooted permanent teeth with wide lesions with apical periodontitis, and the effect on the healing of the periapical tissue and lesion by comparing periapical radyography images, which was taken at the beginning and after one year.
This study aims to evaluate the impact of different root canal filling techniques on postoperative pain levels and the healing of periapical tissues in teeth with periapical lesions, using periapical radiographic imaging. Specifically, the effects of resin-based sealers, bioceramic-based sealers, and two obturation techniques-cold lateral compaction and warm vertical compaction-will be compared. Postoperative pain will be assessed using VAS (Visual Analog Scale) and VRS (Verbal Rating Scale) following the final stage of root canal treatment in incisor and premolar teeth with single roots. Additionally, the healing of periapical lesions will be evaluated by comparing periapical radiographs taken at baseline and at a one-year follow-up. To date, no study has been found in the literature that evaluates these specific combinations of materials and techniques using periapical radiographic imaging.
The study includes four experimental groups based on the combination of obturation technique and sealer type as follows:
Group 1: Cold lateral compaction with AH Plus (epoxy resin-based sealer)
Group 2: Cold lateral compaction with AH Plus Bioceramic (calcium silicate-based sealer)
Group 3: Warm vertical compaction with AH Plus
Group 4: Warm vertical compaction with AH Plus Bioceramic
All treatments will be performed under standardized clinical conditions by an experienced endodontist using a rubber dam in aseptic conditions. Chemomechanical preparation will be done using rotary NiTi instruments and an irrigant protocol consisting of Sodium Hypochlorite (NaOCl), Ethylenediaminetetraacetic Acid (EDTA), and distilled water using Ultrasonic irrigation device. Root canal filling will be performed in a single visit for all patients.
VAS and VRS scores will be recorded at multiple time points postoperatively: immediately after treatment, and at 6, 12, 18, 24, 48, and 72 hours, as well as at 1 week and 1 month. Pain diaries will be provided to all participants.
Radiographic evaluation will be performed using standardized periapical radiographs taken with a parallel technique. Periapical healing will be assessed by comparing lesion size at baseline and at 1 year by two blinded observers.
This study aims to provide clinical data that may guide endodontic decision-making regarding the choice of sealer and obturation technique, particularly in teeth with pre-existing periapical pathology.
246 studies on the registry are indexed under Periapical Periodontitis; 64 are open to participants now.
This study's enrollment of 168 is above the median of 60 across 211 interventional studies indexed under Periapical Periodontitis.
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Exclusion Criteria:
Root canal obturation will be performed using the cold lateral compaction technique with AH Plus epoxy-resin based sealer.
Other: Epoxy Resin-Based Sealer · Procedure: Cold Lateral Compaction
Root canal obturation will be performed using the cold lateral compaction technique with AH Plus Bioceramic sealer.
Other: Bioceramic Sealer · Procedure: Cold Lateral Compaction
Root canal obturation will be performed using the warm vertical compaction technique with AH Plus epoxy-resin based sealer.
Procedure: Warm Vertical Compaction · Other: Epoxy Resin-Based Sealer
Root canal obturation will be performed using the warm vertical compaction technique with AH Plus Bioceramic sealer.
Other: Bioceramic Sealer · Procedure: Warm Vertical Compaction
This intervention involves the use of Bioceramic Sealer during root canal obturation. The sealer will be combined with the cold lateral compaction or warm vertical compaction technique depending on the study arm.
Warm vertical obturation is performed using a heat delivery device, which thermosoftens gutta-percha and allows vertical compaction into the root canal system. This technique will be used in combination with either resin-based or bioceramic sealers, depending on the study group.
This intervention involves the use of an epoxy resin-based root canal sealer during root canal obturation. The material will be applied in combination with either cold lateral compaction or warm vertical compaction techniques, depending on the study group.
Cold lateral compaction is a root canal obturation technique in which a master gutta-percha cone is placed to working length and compacted laterally using a finger spreader. This method will be used in combination with either resin-based or bioceramic sealers, depending on the study group.
Periapical Healing
The primary outcome of this study is periapical healing. It will be assessed radiographically using standardized periapical images (taken with the parallel technique), captured preoperatively and at the 1-year follow-up, and evaluated using the Periapical Index (PAI) score by two blinded observers. The PAI score ranges from 1 (healthy periapical structures) to 5 (severe periodontitis).
Time frame: From end of treatment to 1 year
Post Operative Pain İntensity
The secondary outcome is postoperative pain intensity. Pain will be assessed at multiple time points (6, 12, 18, 24, 48, and 72 hours, and at 1 week and 1 month post-treatment) using Visual Analog Scale (VAS) where 0 represents "no pain" and 10 represents "worst imaginable pain".
Time frame: From end of treatment to 6, 12, 18, 24, 48, and 72 hours; 7 days; and 1 month after root canal treatment
Post Operative Pain Intensity
The secondary outcome is postoperative pain intensity. Pain will be assessed at multiple time points (6, 12, 18, 24, 48, and 72 hours, and at 1 week and 1 month post-treatment) using Verbal Rating Scale (VRS), which categorizes pain into four levels: 0 (no pain), 1 (mild), 2 (moderate), and 3 (severe).
Time frame: From end of treatment to 6, 12, 18, 24, 48, and 72 hours; 7 days; and 1 month after root canal treatment
Plan to share: Yes — All collected individual participant data (IPD), including all IPD that underlie the results reported in the publication
Supporting information: Study protocol, Sap
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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