Pulp Necrosis, Symptomatic Apical Periodontitis
Conditions
Keywords
Periapical Periodontitis, Metformin, Calcium Hydroxide, Intracanal Cryotherapy
Brief summary
This randomized, participant- and outcome assessor-blinded, 2 × 2 factorial clinical trial evaluated the effects of intracanal cryotherapy and two intracanal medicaments-calcium hydroxide and metformin-on postoperative spontaneous and percussion pain in mandibular premolars with pulpal necrosis and symptomatic apical periodontitis. Eighty participants were randomly assigned to four groups: calcium hydroxide, metformin, cryotherapy plus calcium hydroxide, and cryotherapy plus metformin. All teeth underwent standardized two-visit root canal treatment. In the cryotherapy groups, final irrigation at the first treatment visit was performed using sterile saline at 4 °C. Spontaneous pain was assessed preoperatively and daily for 7 postoperative days using a 100-mm visual analog scale (VAS). Percussion pain was assessed preoperatively and on day 7 immediately before the second treatment visit. The effects of cryotherapy, intracanal medicament type, and their interaction were evaluated using mixed-effects modeling for spontaneous pain and analysis of covariance (ANCOVA) for day-7 percussion pain.
Interventions
DRUGPlacement of calcium hydroxide as an intracanal medicament
Calcium hydroxide was applied into the canal after root canal shaping
DRUGPlacement of metformin as an intracanal medicament
Application of metformin as an intracanal medicament following root canal shaping
DRUGApplication of calcium hydroxide as an intracanal medicament together with intracanal cryotherapy
Intracanal cryotherapy with 4 °C sterile saline was applied after root canal shaping and before calcium hydroxide placement.
DRUGApplication of metformin into the canal together with intracanal cryotherapy
Intracanal cryotherapy with 4 °C sterile saline was applied after root canal shaping and before metformin placement.
Sponsors
Celalettin Topbaş
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants and outcome assessors were masked to treatment allocation. The operator was masked to intracanal medicament assignment; however, complete operator masking to cryotherapy allocation could not be guaranteed because of the temperature difference between the irrigation solutions.
Intervention model description
In this randomized, factorial (2 × 2) clinical trial, 80 patients diagnosed with symptomatic apical periodontitis in mandibular premolar teeth were included. Patients were randomly allocated to four groups: calcium hydroxide, metformin, cryotherapy + calcium hydroxide, and cryotherapy + metformin. All teeth underwent standardized two-visit root canal treatment. Postoperative pain was assessed after the first visit, and day-7 outcomes were recorded immediately before the second treatment visit.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Systemically healthy participants. Mandibular premolar teeth diagnosed with pulpal necrosis and symptomatic apical periodontitis and indicated for root canal treatment. Periapical index (PAI) score of 1 or 2. Aged between 18 and 70 years. Able to understand and complete visual analog scale (VAS) assessments. Provided written informed consent.
Exclusion criteria
Any systemic disease or pregnancy. Use of analgesics within 24 hours prior to treatment. Severe bruxism. Presence of acute apical abscess or swelling. Periodontal pocket depth greater than 5 mm or tooth mobility exceeding grade 1. Teeth deemed unrestorable. Presence of vital pulpal tissue or immature apices. Radiographic evidence of root resorption, root fracture, perforation, or canal calcification.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Spontaneous postoperative pain on days 1 to 7 | Days 1 through 7 post-treatment | Spontaneous postoperative pain assessed daily from day 1 to day 7 using a Visual Analog Scale (VAS). Preoperative VAS score is used as a covariate in the statistical analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Day-7 percussion pain | Day 7 post-treatment | Percussion pain assessed on day 7 immediately before the second treatment visit using a Visual Analog Scale (VAS). Preoperative percussion VAS score is used as a covariate in the statistical analysis. |
Countries
Turkey (Türkiye)
Contacts
STUDY_CHAIRAli O ILHAN, DDS
Saglik Bilimleri University
Outcome results
None listed