Comparative study of postoperative pain and healing capacity of two endodontic sealers (AH Plus and NeoSealer Flo)
| ISRCTN | ISRCTN42633118 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN42633118 |
| Secondary identifying numbers | 1.016.017 |
- Submission date
- 29/01/2025
- Registration date
- 18/02/2025
- Last edited
- 06/03/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
This study focuses on apical periodontitis, a common inflammation that can occur when root canal treatments fail. The success of these treatments depends on how well the root canal is sealed. Bioceramic sealants like Neosealer Flo might help improve healing because they are compatible with the body and release calcium ions. The study aims to compare two sealants, AH Plus and Neosealer Flo, in terms of pain after treatment, seal quality, and healing.
Who can participate?
Adults who need root canal treatment and are in good general health can participate in this study.
What does the study involve?
Participants will be randomly assigned to receive either the AH Plus or Neosealer Flo sealant during their root canal treatment. They will be asked to rate their pain at 24 and 48 hours, and again at 7 days after the treatment. The quality of the seal and healing will be checked after 6 months through clinical and radiographic evaluations.
What are the possible benefits and risks of participating?
Participants may benefit from improved healing if the new sealant proves to be more effective. However, there are risks of experiencing pain or discomfort after the treatment, as with any dental procedure.
Where is the study run from?
Centre for Dental Innovation and Specialities of the Universidad Alfonso X el Sabio (Spain)
When is the study starting and how long is it expected to run for?
The study starts in January 2024 and is expected to run until December 2024.
Who is funding the study?
Fundacion Banco de Santander (Spain)
Who is the main contact?
Dr Juan Algar Pinilla, jalgapin@uax.es
Contact information
Scientific, Principal Investigator
Universidad Alfonso X el Sabio, C. de Emilio Muñoz, 13
Madrid
28691
Spain
 ORCID ID |
0000-0002-3616-3210 |
|---|---|
| Phone | +34 913273262 |
| jalgapin@uax.es |
Public
Universidad Alfonso X el Sabio, C. de Emilio Muñoz, 13
Madrid
28691
Spain
| ORCID ID |
0000-0003-0187-4992 |
|---|---|
| Phone | +34 913273262 |
| jaraglam@uax.es |
Study information
| Study design | Interventional single-blind randomized clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | University/medical school/dental school |
| Study type | Treatment, Efficacy |
| Participant information sheet | 46764 PIS.pdf |
| Scientific title | Randomised clinical trial: Effect of AH Plus and Neosealer Flo on postoperative pain and healing of periapical lesions |
| Study acronym | ECA AH VS. NEO |
| Study objectives | H0: There are no statistically significant differences in postoperative pain and healing capacity between the sealers. H1: There are statistically significant differences between the two. |
| Ethics approval(s) |
Approved 14/03/2024, Bioethics Committee of the Universidad Alfonso X el Sabio (C. de Emilio Muñoz, 13, Madrid, 28691, Spain; +34 913273262; investigacion@uax.es), ref: 2024_3/256 |
| Health condition(s) or problem(s) studied | Root canal treatment |
| Intervention | Patients will be treated at the Centre for Dental Innovation and Specialities of Universidad Alfonso X el Sabio, Madrid, Spain. Participants will be randomly assigned into two groups using the online tool random.org: the AH group (treated with AH Plus) and the NEO group (treated with Neosealer Flo). Both operators and patients will remain blinded to the allocated sealer until the obturation phase. Local anesthesia will be administered with 4% articaine and epinephrine to ensure a pain-free and stable working field. The surgical field will be isolated using a rubber dam to minimize contamination and protect soft tissues. Pre-endodontic composite restorations will be placed if necessary to prevent leakage. After caries removal, the pulp chamber will be opened, and root canal orifices located under magnification. Pre-flaring will be performed, and the working length determined with an electronic apex locator and verified radiographically. Root canal instrumentation will proceed with rotary files (Endogal system), alternating with irrigation using 2.5% sodium hypochlorite. Final irrigation will include ultrasonic activation of sodium hypochlorite and a 17% EDTA rinse to remove the smear layer. Obturation will be performed using the vertical compression technique with the allocated sealer. A heated carrier will compact the gutta-percha, and the coronal two-thirds of the canal will be filled with injectable gutta-percha. The canal entrance will be sealed with flowable composite and temporary material. Radiographs will assess obturation quality, ensuring no voids and a final fill within 2 mm of the radiographic apex. Postoperative pain will be assessed using the Numerical Rating Scale (NRS) at baseline, 24, and 48 hours, with patients documenting analgesic use. A 7-day follow-up will include pain reassessment and placement of the final coronal restoration. Clinical and radiographic follow-ups will occur at 6 months to evaluate treatment success. Success will be defined by the absence of clinical symptoms (e.g., pain, inflammation) and radiographic signs of failure, in accordance with AAE criteria. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 1. Postoperative pain is measured using Visual Analog Scale (VAS) at baseline (prior to treatment), 24 hours postoperative, 48 hours postoperative, and 72 hours postoperative 2. State of the lesion is measured using preoperative radiograph at the diagnostic phase and at the 6 month follow-up |
| Secondary outcome measures | 1. Cementum extrusion is measured using visual inspection at the final radiograph of the endodontic treatment |
| Overall study start date | 14/01/2024 |
| Completion date | 31/12/2024 |
Eligibility
| Participant type(s) | Healthy volunteer, Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | Both |
| Target number of participants | 80 |
| Total final enrolment | 70 |
| Key inclusion criteria | 1. Patients over 18 years of age, cooperative and in good general health (ASA class I or II). 2. Have at least one tooth requiring endodontic treatment and provide informed consent for both the treatment and study participation. 3. The resulting RCTs will have to meet the following criteria: 3.1. Root canal obturation within 2 mm of the radiographic apex. 3.2. Absence of voids on the final radiograph. |
| Key exclusion criteria | 1. Teeth with open apices. 2. Coronal cracks extending into the root canal. 3. Root perforations. 4. Severe periodontal disease. 5. Vertical root fractures. |
| Date of first enrolment | 14/03/2024 |
| Date of final enrolment | 30/06/2024 |
Locations
Countries of recruitment
- Spain
Study participating centres
Madrid
28691
Spain
Madrid
28007
Spain
Sponsor information
University/education
C/ Emilio Muñoz, 13
Madrid
28037
Spain
| Phone | +34 913273262 |
|---|---|
| investigacion@uax.es | |
| Website | https://www.uax.com/ |
Funders
Funder type
Industry
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Banco Santander Foundation, Santander Fundación, FBS
- Location
- Spain
Results and Publications
| Intention to publish date | 01/01/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewd journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from (Dr. Juan Algar Pinilla jalgapin@uax.es) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 17/02/2025 | No | Yes |
Additional files
Editorial Notes
06/03/2025: The overall end date was changed from 31/12/2025 to 31/12/2024.
17/02/2025: Trial's existence confirmed by Bioethics Committee of the Universidad Alfonso X el Sabio.
