Dental CariesPhase 2NCT06889363
Clinical and Radiographic Evaluation of Indirect Pulp Capping Using Platelet Rich Fibrin Versus Mineral Trioxide Aggregate in Deep Carious Molars: a Randomized Controlled Trial
A Phase 2 study testing MTA and PRF in people with Dental Caries and Pulp Caping, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this study is the clinical and radiographic evaluation of (Platelet-Rich Fibrin (PRF) versus Mineral Trioxide Aggregate (MTA) in indirect pulp capping when used with deep carious molars over 1 year follow up. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Dental Caries, Pulp Caping, Indirect Pulp Treatment
- What is being tested?
- MTA and PRF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- Jun 2025to Sep 2026
- Phase
- Phase 2
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 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- o Patients with asymptomatic deep carious molars.
- Patients with clinically and radiographically confirmed deep carious lesions that do not exhibit spontaneous pain.
- Permanent molars only.
- Teeth with intact or minimally restored occlusal surfaces (i.e., no extensive restorations or fractures).
- No history of previous endodontic treatment or direct pulp capping on the study tooth.
- No signs of periapical pathology based on radiographic evaluation.
- Patients willing to participate and follow up for 12 months.
- Patients who agree to return for scheduled follow-ups at 3, 6, and 12 months.
Who cannot join
- o Patients with systemic conditions affecting bone or tissue healing (e.g., uncontrolled diabetes, osteoporosis, immunosuppressed conditions).
- Pregnant or lactating women (if applicable to your study).
- Teeth with pulp exposure or necrotic pulp.
- Presence of symptomatic irreversible pulpitis (e.g., spontaneous pain, lingering pain).
- Periapical pathology or internal/external resorption detected radiographically.
- Severely broken down or non-restorable teeth.
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- Calcified root canals or excessive sclerosis that could affect pulp testing reliability.
- Any pre-existing root canal treatment on the selected tooth.
- Patients who have undergone recent fluoride treatment, pulpotomy, or other pulp therapies in the past 6 months.
- Patients using medications affecting bone and tissue regeneration (e.g., bisphosphonates, corticosteroids).
- Patients unwilling or unable to commit to the 12-month follow-up schedule.
- Patients with poor oral hygiene or high caries risk that could compromise treatment outcomes.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Cairo University
Giza, القاهرة - Cairo Governorate, 11585
Eman Ali Abouauf, Assistant Professor, +2001001785300, e.abouauf@dentistry.cu.edu.eg
salma mohammed monir, MSc Cairo university
About this study
The aim of this study is the clinical and radiographic evaluation of (Platelet-Rich Fibrin (PRF) versus Mineral Trioxide Aggregate (MTA) in indirect pulp capping when used with deep carious molars over 1 year follow up.
Read the detailed description
-PICOTS : P: Asymptomatic deep carious molars. I: Indirect pulp capping using PRF. C: Indirect pulp capping using MTA.
O:
Outcome name Measuring device Measuring unit
Primary outcome:
clinical findings : Pulp sensibility using cold test (Sharma A et al., 2020).
Secondary outcome:
Radiographic findings :Dentin bridge measurement in mm using digital radiographic ruler Digital Periapical using paralleling technique (Sharma A et al., 2020).
T:
T0: Baseline T1: 3 months T2: 6 months T3: 12 months S: Randomized clinical trial.
- Research question: Will PRF provide comparable clinical and radiographic outcomes to MTA in indirect pulp capping when used in deep carious molars?
- Conditions
- Dental Caries, Pulp Caping, Indirect Pulp Treatment, Indirect Pulp Cap, Indirect Pulp Capping, Indirect Pulp Therapy
- Being tested
- MTA, PRF
- Keywords
- Molar caries, MTA, PRF, Indirect pulp capping, Deep carious lesion, carious molars, platelet rich fibrin
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MTADrug
Also called mineral trioxide aggregate
The indirect pulp capping will be applied using MTA using an MTA carrier, then glass ionomer will be applied, then composite restoration above
PRFBiological
Also called platelet rich fibrin
The indirect pulp capping will be applied using PRF on a membrane, then glass ionomer will be applied , then composite restoration above
| Study group | Role | What they receive |
|---|---|---|
| Deep carious molars, indirect pulp capping using PRF then GI base then composite restoration | Experimental | Deep carious molars, indirect pulp capping using PRF then GI base then composite restoration Receives: Biological: PRF |
| Deep carious molars, indirect pulp capping using MTA then GI base then composite restoration | Active comparator | Deep carious molars, indirect pulp capping using MTA then GI base then composite restoration Receives: Drug: MTA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulp sensibility using cold test
clinical finding of the investigated tooth measured with binary (yes or no)
Measured: baseline, 3 , 6, 12 months
Secondary outcomes (1)
Radiographic finding
Digital Periapical using paralleling technique (Dentin bridge measurement in mm using digital radiographic ruler)
Measured: baseline, 3 , 6, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study startJun 2025 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by Cairo 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salma Mohamed Monir Mahmoud Ahmed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06889363
- Sponsor's protocol ID
- SALMA.MOHAMED.MONIR.PhD
- Status last verified
- Mar 2025
- First submitted
- 17 Mar 2025
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No