Caries Clinical Trial - Outcome of Pulpotomy Versus Root Canal Therapy

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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: 1. Characteristics of the patient; including age, gender, socioeconomic status, smoking, oral hygiene practices, frequency of dental visits, and dental history. 2. 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. 3. Quality of life instruments designed 4. 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05279781
Study type	Interventional
Source	Jordan University of Science and Technology
Contact	Prof Taha
Phone	+962776566110
Email	n.taha@just.edu.jo
Status	Recruiting
Phase	N/A
Start date	April 1, 2019
Completion date	January 2025

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT05311657` - Oral Health and Severe COPD
Not yet recruiting	`NCT06438926` - Prevalence of Dental Caries in Patients With Dental Crowding
Completed	`NCT01529606` - Cold Plasma for Dental Restoration and Caries Prevention	N/A
Completed	`NCT06072742` - Effect of Lifestyle on Caries and Apical Periodontitis
Completed	`NCT04679558` - Antibacterial Effect of Chlorhexidine Added to the Preventive Protocol in Adolescent Special Needs	Early Phase 1
Active, not recruiting	`NCT04933123` - Clinical Evaluation of a Dental Glass Ceramic in the Indirect Restorative Therapy	N/A
Withdrawn	`NCT02202304` - The Effects of Chlorhexidine/Thymol Varnish on Partial Denture Patient	Phase 4
Not yet recruiting	`NCT04889196` - The Efficiency and Gingival Health Status of Hall Versus SDF Techniques in the Management of Carious Primary Molars	Phase 3
Active, not recruiting	`NCT04708223` - Prospective, Split-mouth, Comparative Study to Compare Clinical Outcomes of Two Different Posterior Composite	N/A
Completed	`NCT06140745` - Evaluation of Dentifrice Formulations to Remineralize Enamel and Dentine Subsurface Lesions in a Double-Blind In-Situ Clinical Trial	N/A
Recruiting	`NCT05144711` - Management of Deep Carious Lesions in Adults	N/A
Not yet recruiting	`NCT03656432` - Effect of CPP-ACP With/Without Fl on White Spot Lesion,Salivary pH and fl Release in High Caries Risk Patients	Phase 3
Not yet recruiting	`NCT02933463` - Clinical Effectiveness of Embrace Wetbond and Clinpro as Pits and Fissure Sealants in Young Permanent Molars	N/A
Completed	`NCT02998814` - Clinical Follow Up of a Fissure Sealant Placed With Different Adhesive Protocols: 2-Year Randomized Split Mouth Study	N/A
Completed	`NCT02027597` - Improving Oral Health With Serious Games	N/A
Not yet recruiting	`NCT05064566` - Evaluation of Caries Detection Methods
Completed	`NCT06010732` - In Situ Comparison of the Remineralization Potential of Optimized Fluoride Dentifrice With Control Fluoride Dentifrice	Phase 3
Recruiting	`NCT05211843` - Saliva Insulin as Biomarker of Risk Factors for Metabolic Dysregulation and Caries	N/A
Not yet recruiting	`NCT05070416` - Lithium Disilicate Crowns Study	N/A
Completed	`NCT02418520` - The Effect of Miswak Chewing Sticks on the Oral Helicobacter Pylori Infection	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.