An interventional study of BioMTA+ and Well-Root PT in Retreatment and Endodontic Diseases, sponsored by TC Erciyes University. Active, not recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by TC Erciyes University · Not applicable, Interventional, and Treatment
Postoperative pain is a common concern following root canal retreatment. The type of root canal filling material and the technique used to place it may influence pain experienced after treatment.
This randomized clinical trial aims to compare the effects of two calcium silicate-based root canal filling materials (BioMTA+ and Well-Root PT) and two placement techniques (manual compaction and reverse-rotation compaction) on postoperative pain following nonsurgical endodontic retreatment.
A total of 56 adult patients requiring root canal retreatment due to persistent inflammation around the root tip will be randomly assigned to four treatment groups. All procedures will be performed in a single visit.
Postoperative pain will be evaluated using a visual analog scale (VAS), and the use of pain-relieving medication will be recorded.
The study aims to determine whether the type of filling material, the placement technique, or their combination influences postoperative pain following nonsurgical root canal retreatment.
Postoperative pain is an important clinical outcome following nonsurgical endodontic retreatment and may be influenced by several factors, including periapical inflammation, mechanical instrumentation, irrigation procedures, root canal filling materials, and obturation techniques.
In endodontic retreatment cases involving loss of apical constriction, achieving adequate apical adaptation and retention of conventional gutta-percha may be challenging. Calcium silicate-based materials have been introduced as alternative filling materials because of their biocompatibility, bioactivity, and sealing properties. However, clinical evidence regarding the influence of different calcium silicate-based materials and their placement techniques on postoperative pain remains limited.
The objective of this prospective, randomized, parallel-group clinical trial is to compare postoperative pain following single-visit nonsurgical endodontic retreatment using two calcium silicate-based filling materials, BioMTA+ and Well-Root PT, applied with either manual compaction or reverse-rotation compaction.
The study will be conducted at the Department of Endodontics, Faculty of Dentistry, Erciyes University, Türkiye.
A total of 56 patients requiring nonsurgical endodontic retreatment of previously treated single-rooted permanent teeth with chronic apical periodontitis will be included.
Following written informed consent, participants will be randomly allocated into four groups, with 14 patients in each group:
Group 1: BioMTA+ with manual compaction.
Group 2: BioMTA+ with reverse-rotation compaction.
Group 3: Well-Root PT with manual compaction.
Group 4: Well-Root PT with reverse-rotation compaction.
Randomization will be performed using a computer-generated randomization sequence. Allocation concealment will be maintained using sequentially numbered, opaque, sealed envelopes. Participants will be blinded to the filling material used; however, operator blinding will not be possible because of the nature of the interventions.
All endodontic retreatment procedures will be performed in a single visit under local anesthesia and rubber dam isolation. Existing root canal filling materials will be removed, and working length will be established using an electronic apex locator and confirmed radiographically.
Root canals will be instrumented using rotary nickel-titanium instruments, with final preparation to size 40/.04. Irrigation will be performed using 5% sodium hypochlorite and 17% ethylenediaminetetraacetic acid (EDTA), followed by final irrigation and drying with paper points.
Depending on group allocation, root canals will be completely filled with either BioMTA+ or Well-Root PT using one of the following placement techniques:
Manual Compaction: The filling material will be introduced into the root canal and compacted using a manual endodontic plugger positioned approximately 1-2 mm short of the working length. Controlled compaction will be performed from the apical toward the coronal region.
Reverse-Rotation Compaction: The filling material will be introduced into the root canal and compacted using a 40/.04 nickel-titanium rotary instrument operated in reverse rotation at 100 rpm. The instrument will be positioned approximately 1 mm short of the working length and activated using controlled movements.
Following obturation, radiographic evaluation will be performed to assess the root canal filling. The coronal restoration will then be completed.
Postoperative pain intensity will be assessed using a visual analog scale (VAS) at predetermined postoperative time points. Patients will be instructed to
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
This study's enrollment of 56 is below the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →TC Erciyes University is the lead sponsor of 349 studies on the registry; 74 are open to participants now.
Counted across the registry records on this site, refreshed daily.
**Inclusion Criteria:**
**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.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this group will undergo single-visit nonsurgical endodontic retreatment. Following root canal preparation and irrigation, the entire root canal will be filled with BioMTA+, a calcium silicate-based filling material. Manual compaction will be performed using an endodontic plugger positioned approximately 1-2 mm short of the working length. The material will be compacted from the apical toward the coronal region using controlled pressure.
Device: BioMTA+
Participants in this group will undergo single-visit nonsurgical endodontic retreatment. Following root canal preparation and irrigation, the entire root canal will be filled with BioMTA+, a calcium silicate-based filling material. Compaction will be performed using a 40/.04 nickel-titanium rotary instrument operated in reverse rotation at 100 rpm. The instrument will be positioned approximately 1 mm short of the working length, and the material will be compacted using controlled movements.
Device: BioMTA+
Participants in this group will undergo single-visit nonsurgical endodontic retreatment. Following root canal preparation and irrigation, the entire root canal will be filled with Well-Root PT, a premixed calcium silicate-based filling material. Manual compaction will be performed using an endodontic plugger positioned approximately 1-2 mm short of the working length. The material will be compacted from the apical toward the coronal region using controlled pressure.
Device: Well-Root PT
Participants in this group will undergo single-visit nonsurgical endodontic retreatment. Following root canal preparation and irrigation, the entire root canal will be filled with Well-Root PT, a premixed calcium silicate-based filling material. Compaction will be performed using a 40/.04 nickel-titanium rotary instrument operated in reverse rotation at 100 rpm. The instrument will be positioned approximately 1 mm short of the working length, and the material will be compacted using controlled movements.
Device: Well-Root PT
BioMTA+ (Cerkamed, Poland) is a powder-liquid calcium silicate-based root canal filling material. Following single-visit nonsurgical endodontic retreatment, the material will be prepared according to the manufacturer's instructions and used to fill the entire root canal. Depending on group allocation, the material will be placed using either manual compaction or reverse-rotation compaction.
Well-Root PT (Vericom, South Korea) is a premixed, ready-to-use calcium silicate-based root canal filling material. Following single-visit nonsurgical endodontic retreatment, the material will be used to fill the entire root canal. Depending on group allocation, the material will be placed using either manual compaction or reverse-rotation compaction.
Postoperative Pain Intensity Assessed Using the Visual Analog Scale (VAS)
Postoperative pain intensity was self-recorded by participants using a numerical rating scale ranging from 0 to 100, where 0 indicated no pain and 100 indicated the worst pain imaginable. Higher scores indicated greater postoperative pain intensity. Pain scores were recorded after the second regenerative endodontic treatment visit.
Time frame: At 6, 12, and 24 hours and daily from Day 2 through Day 7 after the second treatment visit
Postoperative Analgesic Consumption
Participants were instructed to use paracetamol only when postoperative pain persisted. A dose of 250 to 500 mg was recommended according to the participant's age and body weight. The number of paracetamol tablets taken at each assessment time was recorded as 0, 1, or 2. Higher values indicated greater analgesic consumption.
Time frame: At 6, 12, and 24 hours and daily from Day 2 through Day 7 after the second treatment visit
Plan to share: No
No publications or documents are linked to this record.
Ran from Jun 2026 to primary completion in Aug 2026, 2 months.
Of 2,089 non-industry interventional studies with no phase under Pain, Postoperative, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 23. This study's 2 months is below that.
Counting every sponsor, half of 2,102 studies reached it within 11 months; a quarter within 6 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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