Evaluation of Nano Bioactive Glass Combined With i-PRF Scaffold in Vital Pulp Treatments

NCT05902936 | Unknown DMC

• 1 other identifier: ENDO3-7-2
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

With consideration of the previous studies regarding the properties of i-PRF, it will be used in combination with another bioactive material: (Nano-BAG) versus using of i-PRF only as a pulpotomy material with using a premixed bioceramic putty as a coronal sealing material in both cases, to evaluate if there is a difference in the success rate of pulpotomy in case of using Nano-BAG in combination with i-PRF So, in this study the investigators will use Nano-BAG in combination with i-PRF as a material for pulpotomy in cases of mature permanent mandibular molars and compare its outcomes with using i-PRF only and in both cases pulpotomy material will be covered with a layer of premixed bioceramic putty for coronal sealing.

Conditions

Pulpitis - Irreversible; Apical Periodontitis

Outcome Measures

Primary Outcomes (1)

• Pain measurement (change is being assessed)

  Measurement of the change in pain intensity using Visual Analogue Scale from 0 to 10 where higher scores mean higher pain intensity

  After 24 hours and up to 7 days for postoperative pain evaluation using Visual Analogue Scale.

Secondary Outcomes (2)

• Radiographic assesment (change is being assessed)

  at 1 month , 3 months and 6 months

• Tooth sensibility (change is being assessed)

  at 1 month , 3 months and 6 months

Study Arms (2)

Control group

EXPERIMENTAL

After control of bleeding in teeth allocated to the control group i-PRF is to be injected first. The i-PRF will be injected into the root canal to a level 3 mm below the cementoenamel junction (CEJ) then a layer of premixed bioceramic putty is to be added for coronal sealing.

Procedure: Pulpotomy for mature permanent mandibular molars

Intervention group

ACTIVE COMPARATOR

After control of bleeding in teeth allocated to the intervention group, i-PRF is to be mixed with Nano bioactive glass (Nano-BAG) powder to a putty consistency and injected into the root canal to a level 3 mm below the cementoenamel junction (CEJ), then a layer of premixed bioceramic putty is to be added for coronal sealing.

Procedure: Pulpotomy for mature permanent mandibular molars

Interventions

Pulpotomy for mature permanent mandibular molars PROCEDURE

Performing pulpotomy for mature teeth that involves removal of the coronal pulp tissue that is diseased or inflammed followed by placement of a biocompatible material with the intent of maintaining the vitality of the remaining radicular pulp tissue.

Also known as: Vital pulp therapy

Control group; Intervention group

Eligibility Criteria

• Age: 10 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients suffering from symptomatic irreversible pulpitis.
• Tooth should give positive response to cold test
• Heamostatis should be achieved after complete pulpotomy
• Diagnosis is irreversible pulpitis with/without apical periodontitis
• The tooth is restorable and free from advanced periodontal disease
• Tooth is free from cracks or splits
• Patients should be free from any systemic disease that may affect normal healing and predictable outcomes.
• Patients who will agree to the consent and will commit to follow-up period.
• Patients with mature root (closed apices)
• Teeth with no periapical lesion, resorption or widening.
• Soft tissues around the tooth are normal with no swelling or sinus tract
• Mandibular posterior teeth only will be involved.

You may not qualify if:

• Patients with immature root apices.
• Patients with any systemic disease that may affect normal healing.
• Patients with periapical lesions or infections.
• If heamostasis couldn't be achieved within 5-10 minutes
• 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.
• Badly destructed teeth
• Teeth that are non-restorable
• Teeth that require post and core build up

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of oral and dental medicine - Cairo University

Cairo, 11511, Egypt

RECRUITING

MeSH Terms

Conditions

Periapical Periodontitis

Interventions

Pulpotomy

Condition Hierarchy (Ancestors)

Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis

Intervention Hierarchy (Ancestors)

Endodontics; Dentistry

Central Study Contacts

Geraldine Ahmed, Professor

CONTACT

01226322227; geraldine.ahmed@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: * The participant will be blinded to the materials will be used during the pulpotomy process. * The outcome assessors will be blinded. * The operator will not be blinded for both materials during pulpotomy procedure as the two materials having different colors and different handling techniques.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 22, 2023
• First Posted: June 15, 2023
• Study Start: March 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: June 15, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)