Postoperative Pain After One-visit Root Canal Treatment on Teeth With Vital Pulps: Comparison of Two Different Root Filling Techniques
Phase: NA
Conditions: Postoperative Pain, Endodontic Disease, Obturation
Sponsor: Ya-Hsin Yu, DDS, MS

Nov 2016 
 
 
1 
UNIVERSITY OF PENNSYLVANIA  
RESEARCH PROTOCOL  
Protocol Title:  
 
Postoperative pain after one-visit root canal treatment 
on teeth with vital pulps: Comparison of two different 
root filling techniques  
Protocol ID:  
 
825494 
Institution: 
Department of Endodontics School of Dental 
Medicine University of Pennsylvania 
240 S. 40th Street Philadelphia, PA 19104-6033  
215-898-4617 (office) 
215-573-2148 (fax) 
Endodontic Clinic 215-898-6062 (main) 
 
 

Nov 2016 
 
 
2 
Protocol 
 
Objectives  
To investigate and compare postoperative pain after one-visit root canal treatment (RCT) on 
teeth with vital pulps using two different obturation techniques.  
 
Background  
In the past, different obturation techniques have been compared. The study listed below 
compared 2 different techniques with significant findings. The most current technique used, 
single cone with bioceramic sealer, has not been compared. Our project will compare the 
postoperative pain of this technique to another common technique used in our clinic. 
Postoperative pain after one-visit root-canal treatment on teeth with vital pulps: Comparison 
of three different obturation techniques Med Oral Patol Oral Cir Bucal. 2012 Jul 1;17 
(4):e721-7. Luis-O. Alonso-Ezpeleta, Carmen Gasco-Garcia, Lizett Castellanos-Cosano, Jenifer 
Martín-González, Francsico-J. López-Frías, Juan-J. Segura-Egea  
 
Study Design and Ethics  
This prospective clinical trial was reviewed and approved by the institutional review board 
(Protocol ID: 827968). Our study will be a non-randomized clinical trial. Patients will sign a 
dental consent for prior to treatment. Patients participation in the study is voluntary. We will 
perform our normal diagnostic tests to determine the need for root canal treatment and the 
vitality of the tooth. Only vital teeth will be included in this study. Once we have determined 
need for root canal therapy, we will determine if it can be done in one visit. One month we 
will use the warm vertical/AH+ sealer, the next month will use single cone/ bioceramic sealer 
to obturate these teeth. Patients will be asked to complete a pain scale questionnaire before 
treatment and at 4, 24, and 48 hours after completion of treatment. Patient's names, 
insurance, and medical information will not appear on the forms, only a chart number. The 
patients will receive a pre-stamped, pre-addressed envelope to return the surveys. The 
sample size was calculated based on a type I error of 0.05 and the power of 80%. The 
minimum sample size was determined to be 50 patients in each group. We will increase the 
number to compensate the possibility of losing follw-up (Graunaite et al., 2018). 
 
Study duration  
The subjects were recruited for the study from November 2016 to May 2018 during the 
planned eighteen-month period at the Department of Endodontics. 
 
Subject enrollment and inclusion/exclusion criteria 
The study was performed on teeth with vital pulps in patients at least 18 years old. 
Consecutive patients presenting to the Department of Endodontics for routine root canal 
treatment were recruited for the study.  
Inclusion criteria: 

Nov 2016 
 
 
3 
Diagnosis of asymptomatic or symptomatic irreversible pulpitis according to AAE consensus. 
The diagnosis was based on clinical examinations and confirmed upon accessing the teeth.  
Non-contributory medical history (ASA Class I & II) 
Consenting adults age 18 years and older  
Included patients were given oral and written information agreed for participation and 
signed the informed consent 
Record of detailed clinical examinations, including but not limited to percussion/palpation 
testing and periodontal probing. 
 
Exclusion criteria: 
Non-consenting patients and patients below 18 years of age 
Medical history with ASA Class III & IV 
Non-restorable teeth 
Teeth with a non-vital pulp 
Periapical radiolucency showed on the radiographs 
Periodontal probing depths were more than 4mm 
Pre-medication with antibiotics and/or analgesics 24 hours before the treatment 
Patients taking analgesics routinely for non-dental reasons 
 
Treatment Protocol 
Patients will present to the endodontic clinic as needed. If a patient is determined to have a 
diagnosis of irreversible pulpitis, then they will be asked if they would like to participate in the 
study. If a patient chooses not to participate, they will proceed with their root canal treatment 
as needed. If a patient agrees to participate, they will be asked to sign a consent form for 
participation. Patients will be given a questionnaire to complete regarding pain before the 
procedure. At that point, an endodontic resident will perform the root canal treatment and fill 
the root canal with one of the two techniques scheduled that month. At the end of treatment, 
the patient will be given a survey to fill out asked to fill out the survey at 4, 24, and 48 hours 
after the completion on treatment. The survey will be a pain questionnaire on a Visual Analog 
scale (see attached) concerning their level of pain following root canal treatment. Patients are 
typically given a 6 month follow up after root canal treatment, however, there will be no 
follow up concerning our study.  
 
Statistical Analysis 
We compared the VAS scores between the root canal filling techniques using chi-square or 
two-way ANOVA to explore the differences between the groups. Changes in outcome 
variables over time were compared by generalised estimating equation (GEE) analysis, which 
allows for correlation within repeated observations per individual (Liang and Zeger, 1986). 
Statistical analysis of the data was performed with IBM SPSS Statistics Version 23 (IBM Corp, 
Armonk, NY). Statistical significance was set at 0.05 level.