Outcome of Selective & Nonselective Caries Removal in Permanent Teeth
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKing's College London
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Dental patients from routine dental care at ADC (Acute Dental Care) clinics, both undergraduate and postgraduate dental clinics in Guy's Hospital.
Both male and female individuals aged 18 years and older.
Capable of providing informed consent.
Generally, in good overall health from a medical standpoint.
Disqualifiers
Presence of fistulas or swelling.
Involvement of anterior teeth.
Evidence of external or internal root resorption.
Multiple teeth with carious lesions within the same quadrant.
Trial design
Design model
Parallel
Treatments tested in this trial
Selective Caries Removal (No Pulp Exposure)
Procedure/SurgeryCaries excavation technique where clinician leaves carious tissue so close to pulp
Non-Selective Caries Removal (No Pulp exposure)
Procedure/SurgeryComplete caries removal even in areas so close to pulp
Partial Pulpotomy (Pulp Exposed)
Procedure/SurgeryIn caes of Pulp exposure Amputation of inflamed coronal pulp and capping of remaining vital tissue
Treatment groups
168 Participants
are divided into 2 treatment groupsGroup A: Selective Caries RemovalExperimental treatment 2 interventions
Group B: Non selective caries removalExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
After One yearSecondary outcomes
1
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.
Time frame
At 1, 3 and 5 years after the intervention2
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.
Time frame
after one year of the intervention.Locations
Sponsors and contacts
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King's College London
Lead sponsor
Guy's and St Thomas' NHS Foundation Trust
Collaborator
Source ClinicalTrials.gov
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