# Development and Proposal of a Novel Scoring System to Classify Dry Month Severity
## 2 Materials and Methods  
### Study Participants  
The study participants were selected among patients and controls from the Dry Mouth Clinic, who were voluntarily recruited to our previous studies through collaborations with various hospitals in Oslo. The participants were recruited from five different study groups:  
1. primary Sjogren's syndrome patients (pSS) [13].
2. patients with non-Sjogren's syndrome (non-SS), patients with Sjogren's syndrome-like symptoms but who do not fulfil the classification criteria [13; 17].
3. patients who had received radiation therapy for head and neck cancer (HNC) [14].  
(4)  
medicated psychiatric patients (psychiatric patients) [15].  
(5)  
matched controls.  
The patients represent groups of patients with various severities of dry mouth. The pSS and the HNC patients were the most troubled by dry mouth in terms of both xerostomia and hyposulivation, while the non-SS and psychiatric patients were more troubled by xerostomia than hyposulivation [13; 14; 15].  
The control group was recruited through advertisements and had no previous complaints of oral dryness and did not use any medications that affected salivary secretory rate. All patients and controls underwent an extensive oral examination and completed the standardized questionnaires (Table 1).  
To be included, complete sets of data on the General Xerostomia Question (GXQ), Summated Xerostomia Inventory (SXI), Clinical Oral Dryness Score (CODS), unstimulated whole saliva (UWS), and stimulated whole saliva (SWS) were needed. After reviewing the results from the patients and controls, a total of 190 subjects were included in this study (Figure 1). Two pSS patients were excluded due to missing CODS and uncertain diagnosis, one non-SS patient was excluded because CODS was missing, and two controls were excluded because SXI results were not registered.  
All study protocols were approved by the Norwegian Regional Medical Ethical Committee (REK 2015/363, REK 2018/1313, and REK 2021/78549), and the studies were performed in compliance with the tenets of the Declaration of Helsinki. Written informed consent was obtained from all participants prior to inclusion in the studies, and the data was de-identified prior to analysis.  
\begin{table}
\begin{tabular}{l c} \hline
**Questionnaires** & **References** \\ \hline The General Xerostomia Question (GXQ) & [18] \\ \hline The Summated Xerostomia Inventory (SXI) & [19] \\ \hline Complaints of previous oral candidiasis, bad breath (halitosis), bad taste & [20] \\ (dysgeusia), and burning mouth & \\ \hline Subjective evaluation of taste and smell functions (visual analog scale) & [20] \\ \hline The Oral Health Impact Profil-14 (OHIP-14) & [21] \\ \hline The Short Form Health Survey-36 (SF-36) & [22] \\ \hline
**Clinical examinations** & \\ \hline Clinical Oral Dryness Score (CODS) & [23; 24] \\ \hline Measuring unstimulated (UWS) and chewing-stimulated whole saliva (SWS) & [25] \\ \hline Candida growth (swab samples) & [26] \\ \hline Recording of mucosal pathology, dental plaque, tooth mobility, implants and dental caries status & [26] \\ \hline Objective evaluation of taste and smell functions & [27; 28] \\ \hline \end{tabular}
\end{table}
Table 1: An overview of the questionnaires and clinical examinations used in the Dry Mouth Clinic, University of Oslo, Norway.