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Group I (Experimental group I): Lesion Sterilization and Tissue Repair with radicular instrumentation.
Coronal and accessible radicular pulp tissue are extirpated using rotary files. After proper drying, the paste is placed in the cavity and canals.
Group II (Experimental group II): Lesion Sterilization and Tissue Repair with no radicular instrumentation.
Only the coronal pulp is removed, the pulpal floor is covered with triple antibiotic paste with propylene glycol mix.
Group III (Control group): Conventional pulpectomy. Pulp tissue extirpation is done. Biomechanical preparation is done using rotary files with frequent irrigation with Chlorhexidine. The canals are dried using sterile absorbent paper points followed by obturation by the paste of Zinc oxide and eugenol.
The principal investigator will carry out all treatment procedures, and the patients will be assigned into three groups.
For the three interventions "Two test arms and one control group":
Preparation of triple antibiotic paste:
The commercially available antibiotics are taken in separate dappen dishes. The enteric coating of the tablet is removed by scraping the coating with a blade, and for the capsule the outer capsular material is removed. Then each of the components is powdered separately with a clean mortar and pestle. Care should be taken to avoid wetting of powder. At this stage, the powder can be stored separately in tightly capped containers in a dark place or in the refrigerator to prevent exposure to light and moisture. After proper pulverization, each of the components is taken in a clean glass slab/mixing pad. Then a part of propylene glycol as a solvent is dispensed and mixed with equal parts of antibiotics powder to ensure uniform consistency of the mix. The final preparation will be a soft ball-like structure of 1 mm diameter. Resultant opaque paste has to be stored in airtight containers. If the mix turns translucent on storage, it has to be discarded.
Group I (Experimental group I): LSTR with radicular instrumentation. Coronal and accessible radicular pulp tissue are extirpated using rotary files. After proper drying, the paste is placed in the cavity and canals.
Group II (Experimental group II): LSTR with no radicular instrumentation. Only the coronal pulp is removed, the pulpal floor is covered with triple antibiotic paste with propylene glycol mix.
Group III (Control group): Conventional pulpectomy. Pulp tissue extirpation is done. Biomechanical preparation is done using rotary files with frequent irrigation with Chlorhexidine. The canals are dried using sterile absorbent paper points followed by obturation by the paste of ZOE.
For all groups:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LSTR with radicular instrumentation. | Experimental |
| |
| LSTR with no radicular instrumentation. | Experimental |
| |
| Conventional pulpectomy. | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lesion Sterilization and Tissue Repair with radicular instrumentation | Procedure | Coronal and accessible radicular pulp tissue are extirpated using rotary files. After proper drying, the paste is placed in the cavity and the canals. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical success "binary" | Absence of • Spontaneous pain.
| 12 months |
| Radiographic success "binary" | Absence of • Absence of furcation or periapical radiolucency. • Absence of change in the extent of internal or external root resorption other than physiologic resorption. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Child cooperation | Continuous outcome measured on Frankl's scale immediately after the procedure. | Immediately after the intervention |
| Parental satisfaction | Binary outcome measured by direct questioning to parents. "Yes/No" |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gihan M Abuelniel, Professor | Cairo University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo University | Cairo | Egypt |
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| Lesion Sterilization and Tissue Repair without radicular instrumentation | Procedure | Only the coronal pulp is removed, the pulpal floor is covered with triple antibiotic paste with propylene glycol mix. |
|
| Conventional pulpectomy | Procedure | Pulp tissue extirpation is done. Biomechanical preparation is done using rotary files with frequent irrigation with Chlorhexidine. The canals are dried using sterile absorbent paper points followed by obturation by the paste of ZOE. |
|
| Immediately after the intervention |
| Chair side time | Continuous outcome measured in minutes using stopwatch. (After hemostasis is achieved, time will be measured with a stopwatch from the start of the three techniques till the final restoration is performed) | Immediately after the intervention |
| ID | Term |
|---|---|
| D014945 | Wound Healing |
| ID | Term |
|---|---|
| D012038 | Regeneration |
| D001686 | Biological Phenomena |
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