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Clinical and Radiographic Success Following Regenerative Pulpotomy Using Chitosan Hydrogel Versus Platelet Rich Fibrin in Mature Mandibular Molars

Clinical and Radiographic Success Following Regenerative Pulpotomy Using Chitosan Hydrogel Versus Platelet Rich Fibrin in Mature Mandibular Molars: A Randomized Clinical Trial

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06828978
Enrollment
36
Registered
2025-02-17
Start date
2025-02-28
Completion date
2025-08-31
Last updated
2025-02-17

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

Conditions

Regenerative Pulpotomy for Symptomatic Pulpitis of Mandibular Permanent Molars With Mature Apices

Brief summary

The aim of this study is to assess the clinical and radiographic success and postoperative pain in mature mandibular molars following vital pulp therapy using chitosan hydrogel versus platelet rich fibrin.

Interventions

After control of bleeding in teeth allocated to the intervention group, the gel is to be placed into the pulp chamber to a level 3 mm below the cementoenamel junction (CEJ) over the root pulp stumps.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

* Patients suffering from Symptomatic pulpitis in mature mandibular molars only will be involved. * Tooth should give positive response to cold test * Haemostasis should be achieved after full pulpotomy * The tooth is restorable and free from advanced periodontal disease, cracks and splits. * Patients should be free from any systemic disease that may affect normal healing and predictable outcome. * Patients who will agree to the consent and will commit to follow-up period. * Patients with mature root apices * Patients with no internal or external resorption and no periapical lesions * Soft tissues around the tooth are normal with no swelling or sinus tract

Exclusion criteria

* Patients with immature roots. * Haemostasias after 10 minutes cannot be controlled after full pulpotomy Patients with any systemic disease that may affect normal healing. * Patients with periapical lesions or infections. * Pregnant females. * Patients who could/would not participate in a 6 months follow-up. * Patients with fistula or swelling * Patients with necrotic pulp. * Patients with old age.

Design outcomes

Primary

MeasureTime frameDescription
Success Rate6 months (Postoperative)Using Radiographic success criteria by periapical index (Orstavik et al., 1986)

Secondary

MeasureTime frameDescription
Postoperative pain1st day up to 7th dayUsing Modified Visual Analogue Scale for pain with a straight line with one end (point 0) meaning no pain and the other end (point 10) meaning the worst pain imaginable
Tooth sensibility1,3,6 months (postoperative)Using Electric pulp test

Contacts

Primary ContactPerihan A Wafi, Bds
perihan.adel@dentistry.cu.edu.eg01006150247

Outcome results

None listed

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