Clinical and Radiographic Success Rate of Pulpotomy Versus Pulpectomy for Management of Primary Teeth With Deep Caries

Deep Caries Clinical Trial

Official title:

Clinical and Radiographic Success Rate of Pulpotomy Versus Pulpectomy for Management of Primary Teeth With Deep Caries: A Randomized Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06293521
• Other study ID #: 06091995
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: May 16, 2024
• Est. completion date: January 1, 2025

Study information

• Verified date: February 2024
• Source: Cairo University
• Contact: Nada Mostafa, B.D.S
• Phone: 01117311533
• Email: Nadamostafa[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This trial aims to compare treatment outcomes between Pulpotomy and Pulpectomy in treating vital primary teeth diagnosed with deep caries with symptoms of irreversible pulpits

Description:

Background: Pulpectomy is the reference treatment for vital primary molars with irreversible pulpitis.Over the past decades, dental caries has unfailingly been the most common chronic infectious disease of childhood and adults. If remained untreated, it can potentially compromise dental pulp tissue. When the dental pulp of primary teeth is irreversibly inflamed, the first treatment choice is pulpectomy, owing to the well-recognized importance of primary tooth retention for child oral/general health. Although a pulpless tooth can remain functional in the oral cavity, modern pediatric endodontics encourages regenerative approaches in primary teeth.The introduction of calcium silicate-based (CS-B) biomaterials such as mineral trioxide aggregate (MTA), along with further understanding of pulp biology and inflammatory processes, has revolutionized treatment modalities for management of irreversible pulpitis in mature permanent teeth. A growing body of evidence has revealed successful implementation of minimally invasive endodontics, that is, vital pulp therapies (VPTs) for management of permanent teeth with irreversible pulpitis even when associated with apical periodontitis. Due to the traditional notion of poorer healing capacity of primary dental pulp, such a paradigm shift has not been seen in pediatric dentistry.Recent research revealed similar vascular/immune responses of primary and permanent dental pulps to caries; therefore, indicating that their healing potential might be this in mind, a reevaluation of traditional approaches for treatment of inflamed primary pulp seems justified.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: January 1, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 6 Years

Eligibility

Inclusion Criteria:

1. Aged 4 to 6 years , in good general health

2. The parents provided written informed consent.

3. Clinical characteristics, defined as spontaneous pain and the presence of a deep carious lesion with pulp exposure and bleeding that did not halt within five minutes following removal of the coronal pulp tissue.

4. Restorable teeth.

Exclusion Criteria:

1. With systemic disease.

2. Physical or mental disability.

3. Unable to attend follow-up visits.

4. Refusal of participation.

5. Previously accessed teeth.

6. Swelling, tenderness to percussion or palpation, or pathological mobility.

7. Pre-operative radiographic pathology such as resorption (internal or external), per-radicular or furcation radiolucency.

Related Conditions & MeSH terms

• Deep Caries

Intervention

Procedure:
• Pulpotomy
After the chamber is deroofed and coronal pulp is amputated using a round-end fissure bur in a high-speed handpiece with adequate water spray and light pressure until canal orifices were reached, The access cavity is flushed with sterile normal saline solution. Saline-wetted cotton pellets were placed for about 5 minutes over amputation sites applying moderate pressure to control pulpal hemorrhage. After discarding the pellets, blood oozing was present, MTA+ Cerkamed will be manipulated in the ratio of 3:1 (powder: liquid) to obtain a putty mix. This mix will be placed over the radicular pulp with the help of a suitable sterile amalgam carrier. Gentle condensation of the mix will be done in the pulp chamber with a moistened cotton pellet, followed by application of glass ionomer cement.
• Partial Pulpectomy
Pulp tissue extirpation is done. Biomechanical preparation is done using rotary files with frequent irrigation with Chlorhexidine. The canals are dried using sterile absorbent paper points followed by obturation by the paste of Zinc oxide and eugenol. The tooth with then be restored with stainless steel crown

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiographic assessment	Absence of periapical radiolucency or absence of internal/ external root resorption	Month 6 , Month 12
Secondary	Clinical effectiveness	absence of any complication or complementary treatment: Absence of spontaneous pain & Absence of swelling.	Month 3,Month 6,Month 9,Month 12
Secondary	Child cooperation	Modified frankl scale ,Categorical rating (rating 1 is definitly negative; - Rating 5 is definitely positive )	Day 0
Secondary	Time elapsed till final restoration performed	Stopwatch , measured in minutes	Day 0