Treatment Outcomes of Pulpotomy vs. Pulpectomy in Vital Primary Molars With Symptomatic Irreversible Pulpitis

Irreversible Pulpitis Clinical Trial

Official title:

Treatment Outcomes of Pulpotomy Versus Pulpectomy in Vital Primary Molars Diagnosed With Symptomatic Irreversible Pulpitis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06183203
• Other study ID #: BJS-CDC
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 15, 2024
• Est. completion date: June 30, 2027

Study information

• Verified date: February 2024
• Source: Qatar University
• Contact: Joe Cherian, MDS
• Phone: +91-9501708436
• Email: joe.cherian[@]cmcludhiana.in
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This randomised controlled trial aims to compare treatment outcomes between pulpotomy and pulpectomy when used to treat vital primary molars diagnosed with symptomatic irreversible pulpitis. Compared to the standard pulpectomy treatment, pulpotomy is a technically simpler procedure, less time consuming, easier for young patients to tolerate, while retaining the proprioceptive sensation of the tooth - all important advantages when treating young children.

Description:

Background: Pulpectomy continues to be the standard treatment recommendation for management of vital primary molars diagnosed with symptomatic irreversible pulpitis. The recent decade has seen a paradigm shift in the treatment concepts of how vital mature permanent molars diagnosed with irreversible pulpitis can be more conservatively managed using vital pulp therapy techniques like pulpotomy. However, despite emerging evidence indicating similarities between primary and permanent tooth pulp response to dental caries, there is very limited research on whether pulpotomy can be similarly used as a definitive treatment modality for vital primary teeth with irreversible pulpitis. This randomised controlled trial (RCT) aims to compare the treatment effectiveness of pulpotomy versus pulpectomy in management of vital primary molars diagnosed with symptomatic irreversible pulpitis over a two-year period. Methods/Design: This clinical study is a parallel, two-armed, open label, non-inferiority RCT with a 1:1 allocation ratio between the experimental intervention arm (pulpotomy) and the active comparator arm (pulpectomy). Healthy cooperative children, between 4-9 years of age, who have painful primary molars with clinical symptoms typical of irreversible pulpitis will be recruited after obtaining informed consent from their parents/legal guardians. 50 vital primary molars clinically diagnosed with symptomatic irreversible pulpitis will be randomly distributed between the two treatment arms. The primary outcomes that will be assessed are clinical and radiographic success after one-year and two-years of the trial interventions. The influence of baseline pre-operative variables (age; gender; tooth type; site of caries; pre-operative furcal radiolucency; pre-operative pain intensity) and intra-operative factors (time taken to achieve haemostasis) on treatment outcomes will also be assessed. The secondary outcome evaluated will be the immediate (24 h and 7 d) post-operative pain relief for the two treatment interventions. Discussion: This trial seeks to provide evidence on whether pulpotomy treatment can be no worse than the standard pulpectomy treatment for the management of symptomatic irreversible pulpitis in vital primary molars.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: June 30, 2027
• Est. primary completion date: June 30, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 9 Years

Eligibility

Inclusion Criteria:

1. Healthy (ASA I and II) co-operative children (Frankl Scale + and ++) between the ages of four and nine years.

2. Participants have symptoms typical of irreversible pulpitis in one of the primary molars.

3. The pulp of the affected primary molar is vital.

4. Radicular pulp health is confirmed by attainment of radicular pulp haemostasis within 8 minutes of coronal pulp amputation.

5. The affected primary molars can be restored with full coverage crowns.

6. Any physiologic root resorption, if present, is less than ? the root length

Exclusion Criteria:

1. Clinical examination of affected primary molar reveals signs of pulpal infection (e.g. pathologic tooth mobility, parulis/fistula, or soft tissue swelling)

2. Pre-operative periapical radiograph suggests presence of periapical radiolucency.

3. Pre-operative periapical radiograph suggests presence of furcal radiolucency more than ½ the furcation to periapical area.

4. Visual examination of pulp tissue after deroofing reveals signs of necrosis (e.g. avascular/minimally bleeding pulp tissue or yellowish necrotic areas/purulent exudate).

5. Signs of extensive radicular pulp inflammation.

6. Parents not willing to place full coverage crowns post-treatment.

7. Clinical diagnosis of irreversible pulpitis between two primary molars is not sharply defined

Related Conditions & MeSH terms

• Irreversible Pulpitis
• Pulpitis

Intervention

Procedure:
• Pulpotomy
Pulpotomy is a conservative pulp treatment option where only the coronal pulp is removed and a bioactive medicament (MTA) is placed over the remnant radicular pulp after haemostasis is achieved.
• Pulpectomy
Pulpectomy is treatment procedure in primary teeth where the entire coronal and radicular pulp is extirpated and the root canal system filled with a resorbable material (Endoflas)

Locations

Country	Name	City	State
India	Christian Dental College	Ludhiana	Punjab

Sponsors (2)

Lead Sponsor	Collaborator
Nebu Philip	Christian Dental College

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Outcome	Clinical outcome success will be determined at 6-, 12-, and 24-months based on the treated tooth meeting all the below criteria: Treated tooth is not associated with any pain or discomfort; Treated tooth is not associated with tenderness on percussion or palpation; Treated tooth is not associated with any swelling, parulis, or fistula; Treated tooth is not associated with any pathological mobility	6 months; 12 months; 24 months
Primary	Radiographic Outcome	Radiographic outcome success will be determined at 6-, 12-, and 24-months based on the pulpotomy treated tooth meeting all the below criteria: No signs of pathological internal/external root resorption or new furcal/periapical lesions on recall periapical radiographs; Complete radiographic healing or reduction/no change in size of any pre-treatment furcal rarefaction on recall periapical radiographs	6 months; 12 months; 24 months
Secondary	Immediate post-treatment pain relief	Pain scores that will be recorded at 24-hours and 7-days post-treatment using a child friendly Visual Analogue Scale (VAS). The VAS has five-point pain score: 0-No Pain; 1-Mild Pain; 2-Moderate Pain; 3-Severe Pain; and 4-Very Severe Pain.; This VAS pain score will be used to evaluate pain reduction afforded by the treatment intervention.	24 hours; 7 day