RetreatmentNCT07908394
THE EFFECT OF FILLING MATERIAL AND PLACEMENT TECHNIQUE ON POSTOPERATIVE PAIN IN NON-SURGICAL ENDODONTIC RETREATMENT: A RANDOMIZED CLINICAL TRIAL
A study testing BioMTA+ and Well-Root PT in people with Retreatment and Endodontic Diseases, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Retreatment, Endodontic Diseases
- What is being tested?
- BioMTA+ and Well-Root PT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jun 2026to 20 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients aged 18-65 years with ASA physical status I-II.
- Patients who have not used analgesics or antibiotics within the previous 7 days.
- Patients with previously root canal-treated, single-rooted permanent teeth requiring nonsurgical endodontic retreatment.
- Teeth exhibiting radiographic evidence of loss of apical constriction or an enlarged apical foramen.
- Patients with clinically and radiographically diagnosed apical periodontitis.
- Teeth that are restorable and do not require extraction.
Who cannot join
- Patients with diabetes mellitus, immunosuppression, pregnancy, or other medically compromising conditions requiring medication.
- Patients requiring antibiotic prophylaxis.
- Patients with known allergies to materials used during root canal treatment.
- Patients with known allergies to analgesics or antibiotics.
- Teeth with calcified root canals or internal or external root resorption.
- Teeth with immature open apices.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ercıyes Unıversıty Faculty of Dentıstry
Kayseri, 38100
About this study
Official title: THE EFFECT OF TWO DIFFERENT ROOT CANAL FILLING MATERIALS, PLACED USING DIFFERENT TECHNIQUES, ON POSTOPERATIVE PAIN IN NON-SURGICAL ENDODONTIC RETREATMENT: A RANDOMIZED CLINICAL TRIAL
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.
Read more
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.
Read the detailed description
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
- Conditions
- Retreatment, Endodontic Diseases
- Being tested
- BioMTA+, Well-Root PT
- Keywords
- RETREATMENT, POSTOPERATIVE PAIN, Calcium Silicate-Based Materials, Reverse-Rotation Compaction
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioMTA+Device
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 PTDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| BioMTA+ - Manual Compaction | Experimental | 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. Receives: Device: BioMTA+ |
| BioMTA+ - Reverse-Rotation Compaction | Experimental | 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. Receives: Device: BioMTA+ |
| Well-Root PT - Manual Compaction | Experimental | 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. Receives: Device: Well-Root PT |
| Well-Root PT - Reverse-Rotation Compaction | Experimental | 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. Receives: Device: Well-Root PT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 6, 12, and 24 hours and daily from Day 2 through Day 7 after the second treatment visit
Secondary outcomes (1)
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.
Measured: At 6, 12, and 24 hours and daily from Day 2 through Day 7 after the second treatment visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start10 Jun 2026
- Primary completion27 Aug 2026
- Study completion20 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RetreatmentStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is designed as a prospective, randomized, four-arm, parallel-group clinical trial. A total of 56 participants will be randomly allocated into four groups (n=14 per group) in a 1:1:1:1 ratio according to the combination of two calcium silicate-based root canal filling materials (BioMTA+ and Well-Root PT) and two placement techniques (manual compaction and reverse-rotation compaction). All participants will undergo single-visit nonsurgical endodontic retreatment. Postoperative pain intensity and analgesic consumption will be evaluated and compared among the four groups.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Busranur Yavuz, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07908394
- Sponsor's protocol ID
- 2026/154
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECT OF TWO DIFFERENT ROOT CANAL FILLING MATERIALS, PLACED USING DIFFERENT TECHNIQUES, ON POSTOPERATIVE PAIN IN NON-SURGICAL ENDODONTIC RETREATMENT: A RANDOMIZED CLINICAL TRIAL
- ClinicalTrials.gov ID
- NCT07908394
- Acronym / sponsor ID
- 2026/154
- Conditions
- Retreatment, Endodontic Diseases
- Keywords
- RETREATMENT, POSTOPERATIVE PAIN, Calcium Silicate-Based Materials, Reverse-Rotation Compaction
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 56 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 10 Jun 2026 (actual)
- Primary completion
- 27 Aug 2026 (actual)
- Study completion
- 20 Oct 2026 (estimated)
- First posted
- 2 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- This study is designed as a prospective, randomized, four-arm, parallel-group clinical trial. A total of 56 participants will be randomly allocated into four groups (n=14 per group) in a 1:1:1:1 ratio according to the combination of two calcium silicate-based root canal filling materials (BioMTA+ and Well-Root PT) and two placement techniques (manual compaction and reverse-rotation compaction). All participants will undergo single-visit nonsurgical endodontic retreatment. Postoperative pain intensity and analgesic consumption will be evaluated and compared among the four groups.
| Arm | Type | Receives |
|---|---|---|
| BioMTA+ - Manual Compaction | Experimental | 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. 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. |
| BioMTA+ - Reverse-Rotation Compaction | Experimental | 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. |
| Well-Root PT - Manual Compaction | Experimental | Device: Well-Root PTParticipants 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. |
| Well-Root PT - Reverse-Rotation Compaction | Experimental | Device: Well-Root PTParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients aged 18-65 years with ASA physical status I-II.
- Patients who have not used analgesics or antibiotics within the previous 7 days.
- Patients with previously root canal-treated, single-rooted permanent teeth requiring nonsurgical endodontic retreatment.
- Teeth exhibiting radiographic evidence of loss of apical constriction or an enlarged apical foramen.
- Patients with clinically and radiographically diagnosed apical periodontitis.
Key exclusion criteria (6 listed)
- Patients with diabetes mellitus, immunosuppression, pregnancy, or other medically compromising conditions requiring medication.
- Patients requiring antibiotic prophylaxis.
- Patients with known allergies to materials used during root canal treatment.
- Patients with known allergies to analgesics or antibiotics.
- Teeth with calcified root canals or internal or external root resorption.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BioMTA+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. | Device | BioMTA+ - Manual Compaction, BioMTA+ - Reverse-Rotation Compaction |
| Well-Root PTWell-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. | Device | Well-Root PT - Manual Compaction, Well-Root PT - Reverse-Rotation Compaction |
Primary outcome
Postoperative Pain Intensity Assessed Using the Visual Analog Scale (VAS)
Time frame: At 6, 12, and 24 hours and daily from Day 2 through Day 7 after the second treatment visit
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.
1 secondary outcome
Postoperative Analgesic Consumption
Time frame: At 6, 12, and 24 hours and daily from Day 2 through Day 7 after the second treatment visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BioMTA+ and Well-Root PT in people with Retreatment and Endodontic Diseases, run by TC Erciyes University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain Intensity Assessed Using the Visual Analog Scale (VAS) (time frame: At 6, 12, and 24 hours and daily from Day 2 through Day 7 after the second treatment visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.