CGF Partial Pulpotomy Versus Endodontic Treatment (CGF Vs Endo)

February 10, 2026 updated by: Mostafa Kamel Mohamed abdallah, Minia University

Partial Pulpotomy Usung CGF Versus Endodontic Treatment in Treating Irreversibly Inflamed Mature Peramnent Molars

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

partial pulpotomy of mature molars with irrevesible pulptits using CGF in adolescents form 12-17 years old versus endodontic treatment with a 2 years follow up

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Minia City
      • Minya, Minia City, Egypt, 61511
        • Pediatric and Community Dentistry Department , Faculty of Dentistry , Minia University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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:

  1. History of sharp, spontaneous, and lingering pain that was precipitated by thermal provocation and lasted mostly for ≥ 30 seconds.
  2. Early prolonged, intense, and lingering response to cold thermal stimulus and positive response electric pulp test (EPT) at low thresholds.
  3. 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.
  4. 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.
  5. Normal radiographic findings in terms of intact periodontal membrane space

Exclusion Criteria:

Patient-based criteria: Patients with a positive history of the following conditions were excluded:

  1. Emotional or behavioral problems and those receiving antidepressant drugs.
  2. Under treatment with antibacterial or anti-inflammatory medicaments for the last four weeks (Akbal Dincer et al., 2020).
  3. Localized or generalized gingivitis and/or periodontitis with loss of epithelial attachment ≥ 3mm upon probing.
  4. Poor oral hygiene with dense accumulation of calculus or dental plaque.
  5. Systemic conditions such as diabetes, bleeding, immunological disorders.

Tooth-based criteria:

  1. Teeth with abnormal structure or developmental anomalies.
  2. Persistent hemorrhage from the root canal orifices lasting longer than 10 minutes.
  3. Loss of coronal structure beyond restorability

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CGF partial pulpotomy
partial pulpotomy using CGF in mature molars diagnosed with irreversible pulpitis
Procedure: Other treatment
partial pulpotomy using CGF in irreversibly inflamed mature molars in adolescents
Other Names:
  • partial pulpotomy using CGF
Procedure: Other treatment
endodontic treatment using guttapercha in irreversibly inflamed molars in adolescents
Other Names:
  • Endodontic treatment using guttapercha
Active Comparator: Endodontic treatment
Endodontic treatment of mature molars with irreversible pulpitits
Procedure: Other treatment
partial pulpotomy using CGF in irreversibly inflamed mature molars in adolescents
Other Names:
  • partial pulpotomy using CGF
Procedure: Other treatment
endodontic treatment using guttapercha in irreversibly inflamed molars in adolescents
Other Names:
  • Endodontic treatment using guttapercha

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The primary outcome was to compare the cumulative pain responses using modified VAS scores.
Time Frame: one week
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
Time Frame: one week
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical follow up
Time Frame: one week
Assess the absence of pain using VAS pain scale from 0-10
one week
clinical follow up
Time Frame: one week
assess absence or presence of sensitivity to percussion using gentile taping with the back of a metal dental mirror handle.
one week
Radiographic follow up
Time Frame: 2 years
assess the presence or absence of any signs of periapical radiolucency using parallel periapical radiographic dental x-rays using woodpecker digital sensor and its software with the Periapical Index (PAI) which has 5 scores ranging from 1-5 assessing the size of the periapical lesion after 1-, 3-, and 6-month 1 year and 2 years of follow-up
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Minia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 20, 2026

Primary Completion (Estimated)

January 20, 2028

Study Completion (Estimated)

January 25, 2028

Study Registration Dates

First Submitted

January 25, 2026

First Submitted That Met QC Criteria

February 10, 2026

First Posted (Actual)

February 18, 2026

Study Record Updates

Last Update Posted (Actual)

February 18, 2026

Last Update Submitted That Met QC Criteria

February 10, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MiniaU pedo dept

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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