Clinical and Radiographic Success Following Regenerative Pulpotomy Using Chitosan Hydrogel Versus Platelet Rich Fibrin in Mature Mandibular Molars: A Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Cairo University
- Enrollment
- 36
- Primary Endpoint
- Success Rate
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Chitosan Hydrogel after full pulpotomy
Chitosan used as a medicament for pulpotomy as it is non-toxic biocompatible, bioadhesive, biodegradable, has wound healing ability and possesses antimicrobial activity. In addition, it encourages the odontogenic development of dental pulp stem cells.
Intervention: Full Pulpotomy (Procedure)
Platelet Rich Fibrin after full pulpotomy
Platelet-rich fibrin (PRF) is strictly autologous, biocompatible and kind toward pulp, and hence elicits minimal or nil inflammatory response when placed directly over the severed pulp.
Intervention: Full Pulpotomy (Procedure)
Outcomes
Primary Outcomes
Success Rate
Time Frame: 6 months (Postoperative)
Using Radiographic success criteria by periapical index (Orstavik et al., 1986)
Secondary Outcomes
- Postoperative pain(1st day up to 7th day)
- Tooth sensibility(1,3,6 months (postoperative))
Investigators
Perihan Adel Abdel Aziz Wafi
Resident at Faculty of Dentistry
Cairo University