Deep Dental CariesPhase 4NCT06802549
Outcomes of Partial Pulpotomy Treatment in Cariously Exposed Teeth
A Phase 4 study testing Biodentine (calcium silicate-based cement) (Septodont, Saint Maur de Fossés, France) and Theracal PT (resin modified calcium silicate-based cement) (Bisco Inc., Schaumburg, IL, USA) in people with Deep Dental Caries, run by Firat University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this clinical trial is to learn how successful Biodentine and Theracal PT dental filling materials are in treating deep tooth decay in adults. It will also provide information about post-treatment pain. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Deep Dental Caries
- What is being tested?
- Biodentine (calcium silicate-based cement) (Septodont, Saint Maur de Fossés, France) and Theracal PT (resin modified calcium silicate-based cement) (Bisco Inc., Schaumburg, IL, USA)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Mar 2024to 20 Jun 2025
- Phase
- Phase 4
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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- • Patient age should be between 18-50 years
- Should be able to give written informed consent
- Should have systemic status (ASA 1)
- Should have permanent molar or premolar (lower and upper) root development
- Should be asymptomatic, deep (D3) or extremely deep (D4) caries
- Should give vital response in cold test and electric pulp test
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- Should have teeth where the pulp is exposed with caries
- Should not have pain during palpation and percussion
- Should not have periodontal disease
- Should have restorable teeth
- Should have teeth without pulp necrosis, sinus tract or swelling/abscess
- Should have bleeding time less than 10 minutes
- Should be able to include a maximum of two teeth in a patient in the study (should be in different quadrants and there should be at least 2 weeks between treatment periods)
Who cannot join
- Teeth with incomplete root development
- Severely affected teeth that do not respond to pulp sensitivity tests
- Teeth with signs and symptoms of irreversible pulpitis
- Teeth without signs of bleeding after communicating with the pulp chamber
- Teeth with pulp chamber open to the oral environment
- Teeth with periodontal pockets greater than 4 mm deep
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- Teeth with suspected cracks or crown fractures that may be responsible for pulp pathology
- Teeth with uncontrolled bleeding
- Medically at-risk patients will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment Outcomes of Partial Pulpotomy Using Two Different Calcium Silicate Materials in Cariously Exposed Mature Permanent Teeth: A Randomized Clinical Trial
The aim of this clinical trial is to learn how successful Biodentine and Theracal PT dental filling materials are in treating deep tooth decay in adults. It will also provide information about post-treatment pain. The main questions it aims to answer are:
Do Biodentine and Theracal PT dental filling materials treat exposed tooth decay in participants? Do they reduce the need for root canal treatment? After the application of Biodentine and Theracal PT dental filling materials to the participants, the pain and symptoms that cause pain may not decrease. In this case, the tooth may be treated with root canal treatment. The researchers will compare the clinical success of Biodentine and Theracal PT dental filling materials with each other.
Participants will undergo a single-session partial pulpotomy treatment with the dental filling materials mentioned above. Clinical and radiographic follow-ups will then be performed at 3, 6 and 12 months, and records will be kept.
- Conditions
- Deep Dental Caries
- Being tested
- Biodentine (calcium silicate-based cement) (Septodont, Saint Maur de Fossés, France), Theracal PT (resin modified calcium silicate-based cement) (Bisco Inc., Schaumburg, IL, USA)
- Keywords
- deep dental caries, partial pulpotomy, calcium silicate-based material
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biodentine (calcium silicate-based cement) (Septodont, Saint Maur de Fossés, France)Device
It will be placed on the exposed pulp with the help of a carrier and the exposed pulp will be covered with material
Theracal PT (resin modified calcium silicate-based cement) (Bisco Inc., Schaumburg, IL, USA)Device
It will be placed on the exposed pulp with the help of its injection tip and the exposed pulp will be covered with material
| Study group | Role | What they receive |
|---|---|---|
| Partial Pulpotomy with Biodentine | Active comparator | Not described Receives: Device: Biodentine (calcium silicate-based cement) (Septodont, Saint Maur de Fossés, France) |
| Partial Pulpotomy with Theracal PT | Experimental | Not described Receives: Device: Theracal PT (resin modified calcium silicate-based cement) (Bisco Inc., Schaumburg, IL, USA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
"Tooth Survival". Both Clinical and Radiographic Healing Means "Tooth Survival". Clinical Healing; Absence of Clinical Symptoms. Radiographic Healing; Absence of Emerging Periapical Radiolucency.
Clinical and radiographic success at 12 months was defined as tooth survival without clinical symptoms and without newly developed periapical radiolucency. Teeth requiring further endodontic treatment during follow-up were considered treatment failures.
Measured: From enrollment to the end of treatment at 1 year
Secondary outcomes (1)
"Post Operative Pain". It Will be Evaluated With a 10-unit Visual Analog Scale. 0: no Pain, 1-3 Mild Pain, 4-6 Moderate-severe Pain, 7-9 Very Severe Pain, 10 Worst Pain.
Postoperative pain intensity was assessed using a 0-10 visual analog scale (VAS), where 0 represented no pain and 10 represented the worst possible pain. Pain was recorded at 6, 12, 24, 48, and 72 hours and at 1 week after treatment.
Measured: 6, 12, 24, 48, and 72 hours and 1 week after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2025
- Study start20 Mar 2024
- Primary completion15 Jun 2025
- Study completion20 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Deep Dental CariesStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Firat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuba Gök, Firat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06802549
- Sponsor's protocol ID
- FIRATUNI-DENTISTRY-TUBAGOK-002
- Status last verified
- Sep 2026
- First submitted
- 20 Jan 2025
- Last updated
- 20 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Title: Data Sharing for Parial Pulpotomy Treatment in Teeth with Cariously Exposed: The objective of this IPD (Individual Participant Data) sharing plan is to enhance the understanding of the success of partial pulpotomy treatment in cariously exposed teeth using Biodentine and Theracal PT materials, by encouraging and supporting data analysis. Data Access Conditions: Access to the data is available to researchers who present a valid proposal for research purposes and sign a data use agreement. All applications will be reviewed by the study management committee. Data Use: Data may only be used for scientific and ethical research purposes. Data Storage: Data will be stored for a period of ten years following the completion of the study and will be securely disposed of at the end of this period. Data Protection: Data will be stored under strict security protocols and accessible only to authorized personnel.
Publications
Duncan HF. Present status and future directions-Vital pulp treatment and pulp preservation strategies. Int Endod J. 2022 May;55 Suppl 3(Suppl 3):497-511. doi: 10.1111/iej.13688. Epub 2022 Feb 3.
PubMed 35080024Ricucci D, Siqueira JF Jr, Li Y, Tay FR. Vital pulp therapy: histopathology and histobacteriology-based guidelines to treat teeth with deep caries and pulp exposure. J Dent. 2019 Jul;86:41-52. doi: 10.1016/j.jdent.2019.05.022. Epub 2019 May 21.
PubMed 31121241European Society of Endodontology (ESE) developed by:; Duncan HF, Galler KM, Tomson PL, Simon S, El-Karim I, Kundzina R, Krastl G, Dammaschke T, Fransson H, Markvart M, Zehnder M, Bjorndal L. European Society of Endodontology position statement: Management of deep caries and the exposed pulp. Int Endod J. 2019 Jul;52(7):923-934. doi: 10.1111/iej.13080.
PubMed 30664240