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Root canal therapy (RCT) is indicated once the pulp is diagnosed with irreversible pulpitis. Despite favorable success rate reported for RCT in vital cases, it is time consuming, and might increases fracture susceptibility of teeth. With the advancement of materials and better understanding of pulpal healing, vital pulp therapy is practiced as an alternative treatment with high success rate. The aim of this study is to explore the outcome, quality of life and patient satisfaction after full pulpotomy compared to RCT.
Permanent molar teeth with carious pulp exposure and mature roots as evident on the preoperative periapical radiograph will be included in the study. The teeth will be randomly divided into 2 groups (n=30). The first group will be treated with Biodentine full pulpotomy and the second group will be endodontically treated. Based on a previously validated questionnaire. The quality of life and satisfaction of patients after pulpotomy treatment will be evaluated compared to those after endodontic treatment. Clinical and radiographic assessment of the treated teeth will be done 3, 6 and 12 months postoperatively. Pain level will be recorded preoperatively and 1, 2, 3, 5 and 7 days after treatment.
The questionnaire consists of five components:
Characteristics of the patient; including age, gender, socioeconomic status, smoking, oral hygiene practices, frequency of dental visits, and dental history.
Postoperative complications including postoperative pain, discomfort,or swelling.
These symptoms will be evaluated after 1, 2, 3,5 and 7 days by contacting the patient on the phone and at follow up visits at 3, 6, and 12 months.
Quality of life instruments designed
Semantic scales designed to evaluate patient satisfaction with the treatment received.
Clinical and radiographic assessment of the treated teeth will be recorded. Success will be defined as clinically asymptomatic tooth with no sinus tract or swelling or periapical lesion.
Data will be analysed statistically using appropriate tests based on the distribution of the results.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Root canal treatment group | Active Comparator | This group will receive complete root canal therapy |
|
| Pulpotomy group | Active Comparator | This group will receive full pulpotomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non surgical root canal treatment | Procedure | Complete root canal treatment will be performed followed by direct restoration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post operative pain level on numerical pain scale | Pain level after treatment will be assessed on a numerical scale from 0-10 where is zero refer to no pain and 10 is the most sever pain. | 7 days |
| Post operative pain level on visual analogue scale | Pain level after treatment will be assessed on a visual analogy scale from 0-10, where is zero refer to no pain and 10 is the most sever pain. | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical success | The tooth should be pain free, no sinus tract, no tenderness to palpation and no swelling. As measured by clinical examination | 6, 12, 24, 48 months |
| Radiographic success | Periapical x-ray will be taken it should show no bone lesions or root resorption |
| Measure | Description | Time Frame |
|---|---|---|
| The quality of life questionnaire | A questionnaire validated previously by Dugas et al 2002 will be used to assess Quality of life | 6,12, 24, 48 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Prof Taha | Contact | +962776566110 | n.taha@just.edu.jo | |
| Nessrin Taha, PhD | Contact | +962776566110 | nessrin_taha@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Nessrin Taha, PhD | Jordan University of Science and Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jordan University of science and technology | Recruiting | Irbid | 21110 | Jordan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32950193 | Result | Taha NA, About I, Sedgley CM, Messer HH. Conservative Management of Mature Permanent Teeth with Carious Pulp Exposure. J Endod. 2020 Sep;46(9S):S33-S41. doi: 10.1016/j.joen.2020.06.025. |
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After collection of data and publication , data might be made available for the benefit off other researchers
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| ID | Term |
|---|---|
| D011672 | Pulpotomy |
| ID | Term |
|---|---|
| D004708 | Endodontics |
| D003813 | Dentistry |
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Two groups. One will receive root canal treatment t and the other will receive pulpotomy.
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Participant will not be informed whether complete pulp removal or partial treatment was done.
Operator and investigator cannot be blinded due to differences in the procedure and it will be evident on the radiographs, so it cannot be masked during radiographic evaluation.
| Pulpotomy | Procedure | Full pulpotomy followed by direct restoration |
|
| 6, 12, 24, 48 months |