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| ID | Type | Description | Link |
|---|---|---|---|
| main investigator | Registry Identifier | Mahy Abdel Raouf |
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Comparing between different intracanal medications with different combination forms of Modified Triple Antibiotic Paste, Calcium Hydroxide and Chlorehexidine, regarding antimicrobial efficacy through bacterial reduction count of enterococcus Faecalis and regarding clinical and radiographic success in non vital primary teeth necessitating pulpectomy with follow up time 1 year.
1- A mix of modified triple Antibiotic Paste (M-TAP) and normal saline (experimental).
2- A mix of Ca(OH)2 and 2% CHX gluconate solution(experimental). 3- A mix of M-TAP and 2% CHX gluconate solution(experimental). 4- A mix of Ca(OH)2 and normal saline (control) 17) The canals will be dried and filled with intracanal medication plugged into the canal by using a plugger.
18) At the end of the first visit a piece of sterile cotton will be placed in the pulp chamber.
19) All teeth will be dressed with intermediate restorative material (IRM) as a temporary filling, in order to ensure proper sealing with no leakage of any oral fluids inside the root canal, which might disturb the action of the intracanal medication.
20) After 7 days, the temporary restoration will be removed. 21) Disinfection of the operative field will take place as performed previously using the same protocol.
22) Irrigation of the root canals with 2 mL of saline to flush out the medicaments and the third bacteriological sample (S3) will be taken out.
23) Later, canals will be filled with Metapex (Metabiomed, Korea), followed by the placement of stainless-steel crowns (3M ESPE).
24) The samples will be placed in sterile vials with thioglycolate (transport medium). The vials will be sealed tightly to avoid contamination and labeled. The labeled vials will be kept in a freezer and will be sent to the laboratory within 1 hour of collection, and samples will be assessed for total E. faecalis count (Qamar et al., 2023).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Calcium Hydroxide mixed with saline as control intracanal medication | Active Comparator | using calcium hydroxide with saline as control intracanal medication for necrotic primary molars |
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| different types and combinations of intracanal medications for necrotic primary molars | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modified triple antibiotic paste (TAP) mixed with chlorehexidine | Combination Product | M-TAP with CHX 2% |
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| Measure | Description | Time Frame |
|---|---|---|
| Enterococcus faecalis bacterial reduction | Samples from canal using paper point size 20 with pumping action from the widest canal three times one after the access and gaining patency, second one after chemomechanical preparation and the third one after 7 days from intracanal medication insertion in the canal, then the samples will be placed in sterile vials with thioglycolate (transport medium). The vials will be sealed tightly to avoid contamination and labeled. The labeled vials will be kept in a freezer and will be sent to the laboratory within 1 hour of collection, and samples will be assessed for total E. faecalis count. | 3 times, one after the access and gaining patency, second one after chemomechanical preparation and the third one after 7 days from intracanal medication insertion in the canal |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical success | measuring pain through presence or absence of pain Visual inspection of any changes (Redness or swelling of vestibular area (presence or absence of any change) Tenderness upon percussion ( positive or negative response) Tenderness upon touching of the vestibulum ( positive or negative response) | 3,6 and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic success | Digital periapical radiographs for assessing the integrity of the pulp and surrounding structures. Periodontal ligament (PDL) widening, loss of lamina dura, internal or external root resorption, and radiolucency of furcation or periapical pathosis) will be considered as a failure with dichotomous response (yes/no) | 6 and 12 months |
Inclusion Criteria:
• Primary molars necessitating pulpectomy diagnosed with deep dental caries with pulp necrosis, apical periodontitis and periapical pathosis or both.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mahy kamar Mahy A.Raouf Kamar, Assistant Lecturer | Contact | 01550831173 | Mahy_kamar@dentistry.cu.edu.eg |
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| Modified Triple Antibiotic Paste mixed with saline | Combination Product | M-TAP mixed with saline |
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| Calcium Hydroxide mixed with chlorohexidine Intracanal medication | Combination Product | calcium hydroxide powder mixed with CHX 2% solution as intracanal medication |
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| calcium hydroxide mixed with saline as intracanal medication | Combination Product | calcium hydroxide mixed with saline as intracanal medication for necrotic primary molars |
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| ID | Term |
|---|---|
| D010485 | Periapical Periodontitis |
| ID | Term |
|---|---|
| D010483 | Periapical Diseases |
| D007571 | Jaw Diseases |
| D009057 | Stomatognathic Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D010518 | Periodontitis |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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