NCT07417098

Brief Summary

partial pulpotomy of mature molars with irrevesible pulptits using CGF in adolescents

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
20mo left

Started Jan 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress20%
Jan 2026Jan 2028

Study Start

First participant enrolled

January 20, 2026

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

January 25, 2026

Completed
24 days until next milestone

First Posted

Study publicly available on registry

February 18, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2028

Expected
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2028

Last Updated

February 18, 2026

Status Verified

February 1, 2026

Enrollment Period

2 years

First QC Date

January 25, 2026

Last Update Submit

February 10, 2026

Conditions

Irreversible Pulpitis

Keywords

partial pulpotomy , CGF

Outcome Measures

Primary Outcomes (2)

  • The primary outcome was to compare the cumulative pain responses using modified VAS scores.

    The primary outcome was to compare the cumulative pain responses using modified VAS scores which has a scale from 0 -10 after partial pulpotomy using CGF versus Endodontic treatment throughout one week of follow-up period.

    one week

  • Pulpal blood biomarkers

    Measuring Biomarker levels via quantifying NKA, SP, IL-8, and MMP-8 in pg/ml blood after partial pulpotomy using CGF versus Endodontic treatment throughout one week of follow-up period

    one week

Secondary Outcomes (3)

  • clinical follow up

    one week

  • clinical follow up

    one week

  • Radiographic follow up

    2 years

Study Arms (2)

CGF partial pulpotomy

EXPERIMENTAL

partial pulpotomy using CGF in mature molars diagnosed with irreversible pulpitis

Procedure: Other treatment

Endodontic treatment

ACTIVE COMPARATOR

Endodontic treatment of mature molars with irreversible pulpitits

Procedure: Other treatment

Interventions

Other treatmentPROCEDURE

partial pulpotomy using CGF in irreversibly inflamed mature molars in adolescents

Also known as: partial pulpotomy using CGF
CGF partial pulpotomy

Eligibility Criteria

Age11 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Patient-based criteria: Class ASA I or II cooperative adolescents of 11 - 17 years. Based on a 10 cm modified visual analog scale (VAS), only patients who reported a preoperative pain intensity score of ≥ 7, indicative of severe pain were included.
  • Tooth-based criteria: Presence of occlusal extremely deep carious lesion with pulp exposure of mandibular first permanent molars with closed apices (i.e. class V according to Cvek's stages of root development) with sound contralateral molars to provide a reference for biomarker quantification and pulp sensibility tests. Only teeth diagnosed with symptomatic irreversible pulpitis (SIP) were included. To validate the diagnosis of SIP, the teeth with the teeth diagnosed with symptomatic irreversible pulpitis (SIP) were included. To validate the diagnosis of SIP, the teeth with the following criteria were exclusively included:
  • History of sharp, spontaneous, and lingering pain that was precipitated by thermal provocation and lasted mostly for ≥ 30 seconds.
  • Early prolonged, intense, and lingering response to cold thermal stimulus and positive response electric pulp test (EPT) at low thresholds.
  • Normal color and appearance of the tooth surrounding gingival tissues with no evidence of gingival inflammation, swelling, abnormal tooth mobility, or sinus tract or fistula formation upon visual and palpation inspections.
  • Preoperative periapical radiograph with evidence of caries penetrating the entire thickness of the dentin with no isolating radiopaque zone separating the lesion from the pulp indicating extremely deep caries.
  • Normal radiographic findings in terms of intact periodontal membrane space

You may not qualify if:

  • Patient-based criteria: Patients with a positive history of the following conditions were excluded:
  • Emotional or behavioral problems and those receiving antidepressant drugs.
  • Under treatment with antibacterial or anti-inflammatory medicaments for the last four weeks (Akbal Dincer et al., 2020).
  • Localized or generalized gingivitis and/or periodontitis with loss of epithelial attachment ≥ 3mm upon probing.
  • Poor oral hygiene with dense accumulation of calculus or dental plaque.
  • Systemic conditions such as diabetes, bleeding, immunological disorders.
  • Tooth-based criteria:
  • Teeth with abnormal structure or developmental anomalies.
  • Persistent hemorrhage from the root canal orifices lasting longer than 10 minutes.
  • Loss of coronal structure beyond restorability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pediatric and Community Dentistry Department , Faculty of Dentistry , Minia University

Minya, Minia City, 61511, Egypt

Location

Related Publications (4)

  • Nawal RR, Yadav S, Duncan HF, Talwar S, Kaushik A, Singh VK, Koner BC. Discriminatory performance of the pulpal inflammatory biomarkers; Interleukin-8 and TNF-alpha in patients with symptoms indicative of reversible and irreversible pulpitis: A diagnostic accuracy study. Int Endod J. 2024 Sep;57(9):1200-1211. doi: 10.1111/iej.14078. Epub 2024 May 4.

    PMID: 38703070BACKGROUND

  • Sabeti MA, Nikghalb K, Pakzad R, Fouad AF. The Relationship Between Pulpal Diagnostic Conditions and Potential Inflammatory Biomarkers. Int Endod J. 2026 Jan;59(1):23-37. doi: 10.1111/iej.70030. Epub 2025 Sep 9.

    PMID: 40923157BACKGROUND

  • Karrar RN, Cushley S, Duncan HF, Lundy FT, Abushouk SA, Clarke M, El-Karim IA. Molecular biomarkers for objective assessment of symptomatic pulpitis: A systematic review and meta-analysis. Int Endod J. 2023 Oct;56(10):1160-1177. doi: 10.1111/iej.13950. Epub 2023 Jul 17.

    PMID: 37392154BACKGROUND

  • Uesrichai N, Nirunsittirat A, Chuveera P, Srisuwan T, Sastraruji T, Chompu-Inwai P. Partial pulpotomy with two bioactive cements in permanent teeth of 6- to 18-year-old patients with signs and symptoms indicative of irreversible pulpitis: a noninferiority randomized controlled trial. Int Endod J. 2019 Jun;52(6):749-759. doi: 10.1111/iej.13071. Epub 2019 Jan 30.

    PMID: 30638262RESULT

Central Study Contacts

Mostafa Kamel Mohamed, Master's degree

CONTACT

00201096998988Mostafa.kamel@mu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A parallel randomized controlled study that compares partial pulpotomy using CGF with endodontic treatment as a control
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

January 25, 2026

First Posted

February 18, 2026

Study Start

January 20, 2026

Primary Completion (Estimated)

January 20, 2028

Study Completion (Estimated)

January 25, 2028

Last Updated

February 18, 2026

Record last verified: 2026-02

Locations

EG(1)