CGF Partial Pulpotomy Versus Endodontic Treatment

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age11-17
SponsorMinia University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Other treatment

    Procedure/Surgery

    partial pulpotomy using CGF in irreversibly inflamed mature molars in adolescents

  • Other treatment

    Procedure/Surgery

    endodontic treatment using guttapercha in irreversibly inflamed molars in adolescents

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: CGF partial pulpotomyExperimental treatment 1 intervention
Group B: Endodontic treatmentActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
one week
2

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

Time frame
one week

Secondary outcomes

1

clinical follow up

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

Time frame
one week
2

clinical follow up

assess absence or presence of sensitivity to percussion using gentile taping with the back of a metal dental mirror handle.

Time frame
one week
3

Radiographic follow up

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

Time frame
2 years

Other outcomes

Sponsors and contacts

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