Necrotic Pulp
Conditions
Keywords
regeneration, MTA apexification and TAP, revascularization
Brief summary
This study compared the efficiency of pulp revascularization and MTA apexification in the treatment of patients with necrotic immature anterior teeth.
Detailed description
the participants with 66 anterior necrotic immature teeth were randomly assigned into two equal groups with 33 teeth per each, according to regeneration and MTA apexification. At the first visit, all teeth were accessed and irrigated with NaOCl then a TAP was applied as intra-appointment intracanal medication. At the second visit, after removal of the medication with the irrigation, bleeding was initiated into the canal and isolated by the MTA in the orifice in the regeneration group. While in the Apexification group, the MTA was packed apically and all teeth were finally restored with resin composite restorations. The patients were recalled after 1, 3, 6, and 9 months for clinical and radiographic follow up.
Interventions
PROCEDURErevascularization
a sterile sharp needle was used to irritate the apical tissue until bleeding occurred apically in the root canal space so as to create a biological scaffold for the regenerative process
PROCEDUREApexification
a 3-5 mm thickness of MTA using a hand plugger and was verified radiographically.
Sponsors
Enas Ebrahim Sayed
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
For the allocation concealment mechanism, each of 66 papers (each paper was eight folded) numbered from 1 to 66 were, individually packed, in opaque envelopes. Each participant picked an envelope at the beginning of the second visit. The number in the envelope determined which procedure was to be performed for the patient. The partner was to decide the procedure for the operator according to that number.
Intervention model description
participants are allocated at random to receive one of two interventions according to the research plan. In RCT the outcomes are measured, so it is considered a quantitative study . This trial conforms to the Consolidated Standard of Reporting Trials (CONSORT)statement.
Eligibility
Sex/Gender
ALL
Age
7 Years to 16 Years
Healthy volunteers
Yes
Inclusion criteria
* Medically-free patients having immature necrotic anterior teeth (with or without apical periodontitis/abscess) even with previous intervention.
Exclusion criteria
* History of allergy to any of the antibiotics in the tri-mix used in the study * Patients with systemic diseases e.g. Diabetes mellitus, bleeding disorders,… * Psychological disturbance * External / internal root resorption or cystic lesion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity measures | 2 days | self reported pain intesity at 4, 12, 24, and 48 hours.(0= no pain and 100=worst pain) with a scale from 0 to 100 after the two visits. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Resolution of periapical pathosis | 9 months | Radiographically: by comparing radiolucencies in 9 months postoperative radiograph to the baseline radiograph. |
| Amount of radiographic increase in root length: | baseline and 9 months | Root length was measured as a straight line from the cement-enamel junction to the radiographic apex of the tooth in millimeters = (9months follow up length - baseline length) |
| Amount of radiographic increase in the root dentinal wall thickness: | baseline and 9 months | Dentin thickness was measured by =root thickness-pulp space and compared to the baseline radiograph measurements. |
| Decrease of apical diameter: | baseline and 9 months | the diameter of the apical foramen was measured in millimeters and compared to the baseline radiograph measurements |
Outcome results
None listed