Deep Caries Clinical Trial
— RCT-SNCROfficial title:
Randomized Clinical Trial of Treatment Outcomes of Selective Versus Nonselective Caries Removal in Deep Carious Lesions in Permanent Teeth.
Patients presenting with deep decay within permanent teeth presents a common clinical challenge to dentists. The aim of this trial is to compare the success rate of the non-selective caries removal (NSCR) and selective caries removal (SCR) in managing deep caries, as both methods are commonly used in clinical practice. This study will be a randomized controlled trial, with participants divided into two groups: NSCR group and SCR group. Participants of deep caries lesions (reaching more than two-thirds of dentin on periapical radiographs) Both groups will undergo either NSCR or SCR, followed by Partial Pulpotomy (PP) in cases with pulp exposure. Success rates will be assessed at follow-up visits scheduled 1, 3, and 5 years radiographs will be used to assess for pulp health(vitality). The success rate of the two categories will be assessed using a scale that includes factors such as tooth vitality, caries recurrence, and clinical signs of pulpitis. The scale will be applied at follow-up visits. The trial will be conducted in post-graduate dental clinics at Guy's hospital. Deep caries in permanent teeth is a common clinical problem that can lead to pulp exposure and subsequent restorative challenges. The aim of this study is to provide evidence-based guidance for clinicians in managing deep caries lesions, as both NSCR and SCR are commonly used in clinical practice. The results of this study will help clinicians to make informed decisions when choosing the appropriate treatment approach for their patients. In conclusion, this trial aims to compare the success rate of NSCR and SCR in managing deep caries lesions in permanent teeth, as both methods are commonly used in clinical practice. The results of this study will provide valuable insights into the effectiveness of these two treatment approaches and will help clinicians to make informed decisions when choosing the appropriate treatment approaches.
Status | Not yet recruiting |
Enrollment | 168 |
Est. completion date | April 30, 2030 |
Est. primary completion date | April 30, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Dental patients from routine dental care at ADC (Acute Dental Care) clinics, both undergraduate and postgraduate dental clinics in Guy's Hospital. 2. Both male and female individuals aged 18 years and older. 3. Capable of providing informed consent. 4. Generally, in good overall health from a medical standpoint. 5. Possess at least one molar or premolar tooth exhibiting a clinically significant deep carious lesion, with or without carious pulp exposure. 6. Displaying signs and symptoms indicative of a normal pulp or reversible pulpitis. 7. positive response to the cold test (refrigerated gas). 8. Absence of spontaneous pain. 9. Absence of periapical lesions, as determined by routine radiographic examination Exclusion Criteria: 1. Presence of fistulas or swelling. 2. Involvement of anterior teeth. 3. Evidence of external or internal root resorption. 4. Multiple teeth with carious lesions within the same quadrant. 5. Pregnancy in women. 6. Patients under the age of 18. 7. Individuals unable to provide informed consent. 8. Patients who have received antibiotics in the preceding month. 9. Immunocompromised patients. 10. Teeth with tooth surface loss resulting from traumatic parafunctional habits or teeth displaying craze lines. 11. Caries located beneath the gingival margin . 12. Teeth affected by periodontal issues, characterized by bone loss or severe gingival recession. 13. Teeth with pulp exposure where operators cannot achieve hemostasis after applying a cotton pellet soaked with 2.5% sodium hypochlorite (NaOCl) for three cycles, with each cycle consisting of a 2-minute application of NaOCl. 14. People with difficulty to understand the clinical trial concept, procedure and details including language barrier. 15. participants who are involved in other research at the same period of our study. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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King's College London | Guy's and St Thomas' NHS Foundation Trust |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To compare the success rate of maintaining pulp vitality assessed by pulp sensibility test between Selective Caries Removal or Non- Selective Caries Removal techniques after one year of the intervention. | This study aims to compare between reported success rate (maintained pulp vitality) in cases of deep caries lesion when treated by by Selective caries removal and non-selective caries removal.
Pulp sensibility tests will be used to assess the response of the pulp to external stimuli (pulp vitality). The success rate will be calculated as the ratio of cases with maintained pulp vitality to the total treated cases in each group. |
After One year | |
Secondary | Periapical Health Assessment Using Periapical Index Score in Deep Caries Lesion Treatment | The study aims to evaluate periapical health in the treatment of deep caries lesions using selective caries removal and partial pulpotomy. The assessment will be done using the Periapical Index Score. The Periapical Index Score is a standardized scoring system based on radiographic findings, allowing for the identification of healing or failure outcomes. The Periapical Index (PAI) score is a radiographic scale used in endodontics to evaluate the severity of periapical lesions. The scale ranges from 1 to 5, with higher scores indicating more severe periapical pathology. A score of 1 represents no changes, while a score of 5 indicates extensive destruction of periapical tissues. In summary, higher PAI scores correspond to worse outcomes, indicating greater periapical pathology, while lower scores reflect healthier periapical regions. | At 1, 3 and 5 years after the intervention | |
Secondary | Quality of Life Assessment ( Using OHIP-14 questionnaire) in Deep Caries Lesion Treatment: A Comparative Study of Selective Caries Removal and Partial Pulpotomy | This study aims to assess the impact of selective caries removal and partial pulpotomy on the quality of life of participants with deep caries lesions. Quantitative assessment will be done using the Oral Health Impact Profile-14 (OHIP-14). The Oral Health Impact Profile-14 (OHIP-14) is a questionnaire used to measure how oral health affects a person's quality of life. It consists of 14 items and assesses various aspects of oral health-related impact, such as physical discomfort, functional limitations, psychological discomfort, and social disability. The scores on the OHIP-14 range from 0 to 56, with higher scores indicating a greater negative impact on quality of life. In summary, higher OHIP-14 scores signify a worse outcome, indicating a higher burden of oral health problems and a greater impact on daily life functioning. Lower scores indicate a better outcome, reflecting a lesser impact of oral health issues on overall quality of life. | after one year of the intervention. |
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