Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001103358
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
18/03/2026
Date registered
Help: Date registered
7/09/2026
Date last updated
Help: Date last updated
7/09/2026
Date data sharing statement initially provided
Help: Data sharing statement date
7/09/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Oral health–related quality of life and patient satisfaction following non-surgical root canal treatment performed by undergraduate dental students in patients with symptomatic apical periodontitis: A Prospective International Multicenter Clinical Study
Scientific title
Oral health–related quality of life and patient satisfaction following non-surgical root canal treatment performed by undergraduate dental students in patients with symptomatic apical periodontitis: A Prospective International Multicenter Clinical Study
Additional trial identifiers [1] 316797 0
Nil known
Universal Trial Number (UTN)
U1111-1337-5331
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Symptomatic apical periodontitis 341130 0
ASA I and ASA II 343500 0
Condition category
Condition code
Oral and Gastrointestinal 337240 337240 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of the intervention or exposure
Patients with symptomatic apical periodontitis will receive routine root canal treatment by undergraduate dental students. The interventions will take place before the treatment, immediately after obturation, and 6 months and 12 months later (4 intervals), where patients will be examined and asked questions for OHIP-17; and Patient satisfaction surveys.
1. Patient eligibility will be confirmed based on inclusion/exclusion criteria assessed by a faculty member and written informed consent will be obtained.
2. The following baseline data will be recorded: gender, age, medical history, tooth type, tenderness to percussion and/or palpation, positive bite test, sinus tract, abscess, facial swelling, periodontal probing depths, mobility, periapical lesion (present or absent), number of proximal contacts, whether the tooth was functional, and contact details (address, phone number, email etc). Additionally, restorative materials (present or absent); if present, specify the materials, such as amalgam or composite. The study will include a minimum of two to five dental schools from different countries.
3. Patients will complete two questionnaires: OHIP-17 and Patient satisfaction.
4. Each patient will be scheduled for non-surgical root canal treatment (NSRCT) performed by an undergraduate student under direct faculty supervision. Standardized treatment protocols will be followed across all participating centres to ensure consistency (including local anaesthesia, rubber dam isolation, chemo-mechanical preparation, irrigation, and obturation).
5. NSRCT will be completed over one or more visits as clinically indicated. Students will document procedural details, including number of visits, instrumentation technique, irrigants, and any intraoperative complications.
6. Upon completion of treatment, patients will complete the two questionnaires to assess immediate changes in Oral Health-related Quality of Life and treatment satisfaction.
Intervention code [1] 333486 0
Diagnosis / Prognosis
Description of the comparator or control
No control/comparator group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 344758 0
Treated tooth conditions
Timepoint [1] 344758 0
Preoperatively, immediately after the treatment completion, and 6 and 12 months post-treatment
Primary outcome [2] 346057 0
Oral health–related quality of life
Timepoint [2] 346057 0
Preoperatively, immediately after the treatment completion, and 6 and 12 months post-treatment
Primary outcome [3] 346058 0
Patient satisfaction
Timepoint [3] 346058 0
Preoperatively, immediately after the treatment completion, and 6 and 12 months post-treatment
Secondary outcome [1] 459114 0
nil
Timepoint [1] 459114 0
nil

Eligibility
Key inclusion criteria
1. Adults Patients aged between 18 years and 65 years presenting with teeth diagnosed with symptomatic apical periodontitis
2. Patients undergoing non-surgical root canal treatment performed by final-year undergraduate dental students (the year prior to internship).
3. Willingness to provide informed consent, complete study questionnaires, and attend follow-up visits as required by the study protocol.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
1. Teeth that have undergone prior root canal treatment on the same tooth.
2. Teeth exhibiting mobility, fractures, open apex, or abscess.
3. Patients with systemic conditions or immunocompromised states that may impair healing (e.g., uncontrolled diabetes or undergoing chemotherapy).
4. Pregnant women.
5. Patients who are unable to comprehend or complete study questionnaires due to cognitive or language limitations.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
7/09/2026
Actual
Date of last participant enrolment
Anticipated
1/01/2027
Actual
Date of last data collection
Anticipated
1/12/2028
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment outside Australia
Country [1] 27943 0
United Arab Emirates
State/province [1] 27943 0
Sharjah

Funding & Sponsors
Funding source category [1] 321392 0
University
Name [1] 321392 0
University of Sharjah
Country [1] 321392 0
United Arab Emirates
Primary sponsor type
University
Name
University of Sharjah
Address
Country
United Arab Emirates
Secondary sponsor category [1] 325261 0
None
Name [1] 325261 0
Address [1] 325261 0
Country [1] 325261 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 319933 0
University of Sharjah (Office of Vice Chancellor for Research & Graduate Studies - Research Ethics Unit)
Ethics committee address [1] 319933 0
Ethics committee country [1] 319933 0
United Arab Emirates
Date submitted for ethics approval [1] 319933 0
08/12/2025
Approval date [1] 319933 0
19/01/2026
Ethics approval number [1] 319933 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 148866 0
Prof Ahmed Jamleh
Address 148866 0
University of Sharjah, University City Road, University City, P.O. Box 27272, Sharjah, United Arab Emirates
Country 148866 0
United Arab Emirates
Phone 148866 0
+971501748211
Fax 148866 0
Email 148866 0
[email protected]
Contact person for public queries
Name 148867 0
Ahmed Jamleh
Address 148867 0
University of Sharjah, University City Road, University City, P.O. Box 27272, Sharjah, United Arab Emirates
Country 148867 0
United Arab Emirates
Phone 148867 0
+971501748211
Fax 148867 0
Email 148867 0
[email protected]
Contact person for scientific queries
Name 148868 0
Ahmed Jamleh
Address 148868 0
University of Sharjah, University City Road, University City, P.O. Box 27272, Sharjah, United Arab Emirates
Country 148868 0
United Arab Emirates
Phone 148868 0
+971501748211
Fax 148868 0
Email 148868 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
What individual participant data might be shared?
• De-identified individual participant data:
• Published results
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
• Studies exploring new research questions
• Studies testing whether findings can be repeated or confirmed
• Teaching research methods or developing new statistical techniques
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
A finite period of: 5 years
Where can requests to access individual participant data be made, or data be obtained directly?
• Data repository: to be shared when requested

• Journal publication or its supplementary materials: Published papers can be shared

• Email of trial custodian, sponsor or committee: Ahmed Jamleh
University of Sharjah, University City Road, University City, Sharjah, P.O. Box 27272, United Arab Emirates

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.