Does zinc supplementation reduce the incidence of recurrent aphthous stomatitis?
- Conditions
- Health Condition 1: K120- Recurrent oral aphthae
- Registration Number
- CTRI/2023/11/060114
- Lead Sponsor
- Peoples College of Dental Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Participants for the study were sourced from the local population, with an array of specific criteria needing to be met for inclusion. Firstly, the age of the participants was a key factor; only individuals ranging from 18 to 60 years of age were considered. Additionally, all participants were required to have a confirmed diagnosis of recurrent aphthous stomatitis (RAS), with a minimum of four episodes occurring in the past year. A crucial aspect of the medical history was the absence of known allergies to zinc or any contraindications pertaining to zinc supplementation, to ensure the safety and health of the participants. Finally, the ability to offer informed consent for participation in the study was essential, safeguarding the ethical integrity of the research process. Thus, all participants were required to actively acknowledge and understand the implications of the study before proceeding with participation.
The recruitment of study participants was conducted within the local population, with a set of specific inclusion criteria applied to ensure the suitability and safety of the individuals involved. The age bracket for participation was strictly defined, with only individuals aged between 18 and 60 years considered eligible. A key medical requirement was a confirmed diagnosis of recurrent aphthous stomatitis (RAS), with participants having experienced at least four episodes within the preceding year. Furthermore, a clean medical history in relation to zinc was crucial, which meant that participants could not have any known allergies to zinc or any contraindications for its supplementation. Lastly, an ethical cornerstone of the recruitment process was informed consent. Participants were required to demonstrate the ability to understand the implications of their involvement and to willingly consent to participate in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome was the incidence of RAS episodes during the 12-week intervention period.Timepoint: 12 weeks
- Secondary Outcome Measures
Name Time Method Secondary outcomes included the duration and severity of RAS episodes, quality of life assessments using validated questionnaires (e.g., Oral Health Impact Profile), and the occurrence of adverse events related to zinc supplementation.Timepoint: 12 weeks