Clinical trial NCT03120845: Incidence of Post-operative Pain After Single-visit Versus Two-visit Treatment
Official title: Incidence of Post-operative Pain After Single-visit Versus Two-visit Root Canal Treatment of Teeth With Necrotic Pulp and Apical Periodontitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-operative Pain
Keywords: Pain,
one-visit
two visits
Lead sponsor: Universidad Autonoma de Baja California
Sponsor class: OTHER
First posted: 2017-04-19
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Ibuprofen for post operative pain. after RCT in one visit
Primary purpose: TREATMENT

Brief summary: Aim :to compare incidence of post-operative pain and apical healing after single-visit versus two-visit root canal treatment of teeth with necrotic pulp and apical periodontitis.

Detailed description: Aim to compare incidence of post-operative pain and apical healing after single-visit versus two-visit root canal treatment of teeth with necrotic pulp and apical periodontitis.

Methodology: All teeth of the one and two-visit group were asymptomatic (92) and symptomatic (18) with a diagnosis of pulp necrosis (RCT cases) determined by hot and cold sensitivity tests and radiographically all teeth showed a small and irregular radiolucency at the tooth apex. Working length was established with EAL and confirmed radiographically. Reciprocating files (VDW, Munich Germany) were used to complete root canal preparation. EDTA served as a lubricant.

Eligibility criteria: Inclusion Criteria:

1. The aims and requirements of the study were freely accepted;
2. Treatment was limited to patients in good health;
3. All teeth had nonvital pulps and apical periodontitis, with or without a sinus tract;
4. A negative response to hot and cold pulp sensitivity tests;
5. Presence of sufficient coronal tooth structure for rubber dam isolation;
6. No prior endodontic treatment on the involved tooth
7. No analgesics or antibiotics were used five days before the clinical procedures began.

Exclusion Criteria:

1. Patients who did not meet inclusion requirements;
2. Patients who did not provide authorization for participation;
3. Patients who were younger than 16 years old;
4. Patients who were pregnant;
5. Patients who were diabetic;
6. Patients with a positive history of antibiotic use within the past month;
7. Patients whose tooth had been previously accessed or endodontically treated;
8. Teeth with root resorption,
9. Immature/open apex, or a root canal in which patency of the apical foramen could not be established were all excluded from the study. Teeth with periodontal pockets deeper than 4 mm also were excluded of the study.

Primary outcomes:
measure: Post-operative pain in one visit
timeFrame: one week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: SECRETARIA DE SALUD
name: Miguel O Osuna, DDS
role: STUDY_CHAIR
References:
citation: Paredes-Vieyra J, Enriquez FJ. Success rate of single- versus two-visit root canal treatment of teeth with apical periodontitis: a randomized controlled trial. J Endod. 2012 Sep;38(9):1164-9. doi: 10.1016/j.joen.2012.05.021. Epub 2012 Jul 26.