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This study will be conducted to clinically evaluate the efficacy of human treated dentine matrix paste and Platelet rich fibrin (PRF) in induction of root formation of non-vital immature permanent teeth.
A) Patient grouping:
Patients will be randomly allocated into 2 groups using sealed envelope method of randomization
Group (A):
Teeth to be treated by h-TDM paste (n=10).
Group (B):
Teeth to be treated by platelet rich fibrin (PRF) regeneration (n=10).
B) Procedures:
Diagnosis of pulp necrosis, clinical and radiographic examination. 11 For each patient, the protocol of treatment is composed of 7 sessions. The follow-up takes place over a 15 months' period. Day 0 is considered as the day of the first treatment session.
I- Day 0:
Pre-operative Cone Beam Computed Tomography (CBCT) is taken at this visit.
Calcium hydroxide canal conditioning for 2 weeks regardless of the treatment group. This is done in the following sequence:
II- Day 0+15:
This session starts with administration of local anesthesia, placement of a rubber dam and the removal of all the calcium hydroxide by copious saline irrigation. Then, treatment according to the assigned group:
Group A (h-TDM paste):
Preparation of h-TDM:
Mentioned before.
Preparation of h-TDM paste:
Mentioned before. 3- Operative procedures:
Group B (PRF regeneration):
13
III- 3 months:
Clinical and radiographic control for all patients.
IV- 6 months:
Clinical and radiographic control for all patients.
V- 9 months:
Clinical and radiographic control for all patients.
VI- 12 months:
• Clinical and radiographic control for all patients.
VII- 15 months:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treated Dentine Matrix (TDM) | Experimental | Participants treated with TDM paste |
|
| Platelet Rich Fibrin (PRF) | Experimental | Participants treated with PRF |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Regenerative endodontic procedues | Other | Treating non-vital immature permanent teeth with either treated dentine matrix paste or platelet rich fibrin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical evaluation | Clinically evaluating the efficacy of human treated dentine matrix paste and Platelet rich fibrin (PRF) in induction of root formation of non-vital immature permanent teeth. | 15 months |
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic evaluation | Radiographically evaluating the efficacy of human treated dentine matrix paste and Platelet rich fibrin (PRF) in induction of root formation of non-vital immature permanent teeth. | 15 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohamed A Asal, MDS | Mansoura University | Principal Investigator |
| Ibrahim H Elkalla, PhD | Mansoura University | Study Chair |
| Yousry M Elhawary, PhD | Mansoura University | Study Director |
| Ashraf Y Alhsoainy, PhD | Mansoura University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry, Mansoura University | Al Mansurah | Dakahlia Governorate | 35511 | Egypt |
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| ID | Term |
|---|---|
| D003790 | Dental Pulp Necrosis |
| ID | Term |
|---|---|
| D003788 | Dental Pulp Diseases |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D009336 | Necrosis |
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| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |