Clinical and Radiographic Evaluation in Pulpotomy of Primary Molars Using Protooth Vs. MTA

Clinical and Radiographic Evaluation in Pulpotomy of Primary Molars Using Novel Fast-setting Calcium Silicate Cement (Protooth) Versus Mineral Trioxide Aggregate (MTA): A Pilot Study

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04710160

Enrollment

Registered

2021-01-14

Start date

2021-08-31

Completion date

2022-11-30

Last updated

2021-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clinical Evaluation Including Pain and Swelling

Keywords

Pulpotomy , Primary molars , Protooth , MTA

Brief summary

The aim of the study is to evaluate the clinical and radiographic success in pulpotomy using novel fast-setting calcium silicate cement (Protooth) versus MTA in exposed primary molars.

Interventions

DRUGNovel fast-setting calcium silicate cement (Protooth)

In form of power and liquid to be mixed together to form a paste.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

4 Years to 8 Years

Healthy volunteers

Yes

Inclusion criteria

* Complete physical and mental health, with no confounding history of systemic disease and/or use of special local or systemic drugs * No allergic reactions recorded in patient history * Having primary molar teeth in one jaw, having deep caries and vital pulp. * No history of spontaneous pain, pathologic mobility, draining sinus tract, redness or swelling of vestibule * Normal gingival and periodontal condition, with no sensitivity to vestibular palpation, and no pain on percussion test * Radiographic criteria: * No sign of radiolucency in periapical or furcation area * No widening of PDL space or loss of lamina dura continuity * No evidence of internal/external pathologic root resorption

Exclusion criteria

* Lack of informed consent by the child patient's parent * Lack of informed consent by the child patient's parent * Unable to attend follow-up visits. * Refusal of participation.

Design outcomes

Primary

Measure	Time frame	Description
Clinical evaluation including postoperative pain , pain on percussion or palpation will be measured using VAS	12 months	Post-operative pain following pulpotomy treatment will be measured. A pain chart using visual analogue scale (VAS) will be used to record the patients' pain levels. The VAS (0-10 scale) consists of a line anchored by two extremes No pain and the worst pain. Patients will be asked to choose the mark that represented their level of pain from 0 to 10. Pain level will be assigned as follow: 0, no pain 1-3, mild pain 4-6, moderate pain 7-10, severe pain Using the VAS chart, the patient will choose and record the most appropriate pain rating according to the pain intensity endured.

Secondary

Measure	Time frame	Description
Radiographic evaluation following the Pulpotomy treatment will be measured	12 months	Binary assessment of the radiographs taken after the treatment ( if there is any radiolucent or widening in the lamina sure nor evidence of internal/external pathologic root resorption)

Countries

Egypt

Contacts

Primary ContactAdel Elbardissy, professor

adelbardissy@dentistry.cu.edu.eg01271289999

Backup ContactPassant Nagy, Doctorat

passant.nagi@dentistry.cu.edu.eg0128557107

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026