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NCT Number: NCT07417098

CGF Partial Pulpotomy Versus Endodontic Treatment

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

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Key information

Age range

11 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Minya, Minia City, 61511, Egypt

Location contact

Ahmad Elheeny, professor

CONTACT

[email protected]

00201064257135

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:

  • 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

Exclusion criteria

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

Treatment and study plan

Other treatment

Procedure

partial pulpotomy using CGF in irreversibly inflamed mature molars in adolescents

Other names: partial pulpotomy using CGF

Primary outcomes

  1. 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.

  2. 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

Secondary outcomes

  1. clinical follow up

    Time frame: one week

    Assess the absence of pain using VAS pain scale from 0-10

  2. 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.

  3. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Mostafa Kamel Mohamed, Master's degree

CONTACT

[email protected]

00201096998988

Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Official study title

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

Acronym: CGF Vs Endo

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Feb 18, 2026
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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