Effect of Different Root Canal Disinfection Procedures on Postoperative Pain: A One-Week Follow-Up Clinical Study
Phase: NA
Conditions: Pain, Postoperative
Sponsor: Cumhuriyet University

INFORMED CONSENT FORM 
 
 
Official Title of the Study: 
Evaluation of the Effect of Different Root Canal Disinfection Procedures on Postoperative Pain 
 
ClinicalTrials.gov Identifier: 
NCT number not yet assigned 
 
Document Type: 
Informed Consent Form 
 
Ethics Committee: 
Sivas Cumhuriyet University Clinical Research Ethics Committee 
 
Document Date: 
15 December 2022 
 
 
Dear Participant, 
 
The study you are invited to participate in is a scientific research study entitled “Evaluation of 
the Effect of Different Root Canal Disinfection Procedures on Postoperative Pain.” The aim of 
this study is to evaluate the effect of different root canal cleaning and disinfection procedures, 
particularly on postoperative pain following root canal treatment. 
 
This study does not pose any additional risk or harm to you beyond routine clinical procedures. 
However, as with standard root canal treatment, potential complications such as instrument 
fracture within the root canal, root perforation, severe postoperative pain, or swelling may occur 
during or after the procedure. 
 

Participation in this study is entirely voluntary. Before making your decision, we would like to 
provide you with detailed information about the study. If you decide to participate after reading 
and understanding this information, please sign this form. 
 
To be eligible for inclusion in this study, you must be between 18 and 65 years of age, regardless 
of gender; the single-rooted tooth to be treated must not present with spontaneous pain or 
swelling; you must not have used analgesics within the last 12 hours or antibiotics within the 
last one week prior to the procedure. Female participants must not be pregnant or breastfeeding. 
 
As a participant, you are expected to perform the requested pain assessments at the specified 
dates and times, respond accurately and appropriately to the investigator’s questions, and 
deliver the results to the investigator in a timely manner. 
 
If you agree to participate, you will be examined by Assoc. Prof. Demet ALTUNBAŞ or a 
dentist appointed by her, and your clinical findings will be recorded. 
 
In this study, root canal treatment will be performed under local anesthesia with rubber dam 
isolation. Any existing caries will be removed, previous restorations will be eliminated, and the 
root canal will be mechanically prepared. Following preparation, the irrigation and disinfection 
protocol corresponding to the group to which you are randomly assigned—determined at the 
beginning of the study by a computer-generated randomization program—will be applied. 
 
All procedures routinely performed during standard root canal treatment will also be applied to 
you. The irrigation and disinfection procedures used in this study are all intended to remove 
debris and microorganisms from the root canal system and provide similar therapeutic effects. 
However, due to factors such as higher cost, space requirements, limited practicality in high-
patient-volume clinics, and longer application time, some adjunctive disinfection procedures 
are not routinely used despite their potential to offer more effective treatment. 
 
Following completion of all disinfection procedures, the root canal will be obturated. After 
treatment, you will be asked to record the intensity of pain you experience at 6, 24, 48, and 72 
hours, as well as on the 7th day, by marking the appropriate point on a 0–100 mm visual analog 
scale provided in the patient evaluation forms. 
 
Routine follow-ups will be conducted for seven days through in-person clinical visits or 
telephone communication. At the end of one week, you will be asked to return to our clinic with 

the completed pain assessment form for evaluation. A total of 80 volunteers will be included in 
this study, which will have a duration of 24 months. 
 
Ağrı yok                                                                                       çok şiddetli ağrı 
      
    0                                                                                                               100      
 
If any new information arises during the study that may affect your willingness to continue 
participation, you or your legal representative will be informed immediately. 
 
For additional information about the study or in case of any problems, adverse effects, or 
discomfort related to the study, you may contact the investigator Research Assistant Dentist 
İbrahim AKDENİZ at +90 543 498 71 18. 
 
All examinations, tests, procedures, and medical care provided within the scope of this study 
will be free of charge. No fees will be requested from you or your social security institution. 
Any health problems arising directly or indirectly from the research procedures will be treated 
by the responsible investigator, and no financial burden will be imposed on you for medical 
interventions. 
 
Participation in this study is entirely voluntary. You may refuse to participate or withdraw from 
the study at any time without any penalty or loss of benefits. The investigator may also withdraw 
you from the study if you fail to comply with the treatment protocol, disrupt the study schedule, 
or for reasons such as enhancing treatment efficacy. 
 
The results of this study will be used for scientific purposes only. If you withdraw from the 
study or are withdrawn by the investigator, your medical data will not be used. 
 
All your medical and personal identification information will be kept confidential. Even if the 
study is published, your identity will not be disclosed. However, study investigators, monitors, 
ethics committees, and authorized regulatory authorities may access your medical records when 
necessary. You have the right to access your own medical information upon request. 
 
Consent to Participate 
 

(This section will be handwritten by the volunteer.) 
 
I have read and listened to the information provided above prior to the initiation of the study. I 
have asked the investigator all questions that came to mind, and I fully understand all written 
and verbal explanations given to me. I was given sufficient time to decide whether or not to 
participate in the study. Under these conditions, I authorize the study investigators to review, 
transfer, and process my medical data, and I voluntarily accept the invitation to participate in 
this study without any coercion or pressure. 
 
A signed copy of this consent form will be provided to me. 
 
Volunteer: 
Name and Surname: 
Address: 
Telephone/Fax: 
Date and Signature: 
 
Investigator Providing Information: 
Name and Surname: 
Title: 
Address: 
Telephone/Fax: 
Date and Signature: 
 
Witness to the Consent Process: 
Name and Surname: 
Title: 
Address: 
Telephone/Fax: 
Date and Signature: