We conducted a cross-sectional study on 1900 people of Iranian adults (age>=40) residing in different cities of Golestan province from April 2018 to March 2019. Testing was done in the form of information obtained through the health centers of Gorgan and Gonbad cities and neighboring cities, and the testing in all centers lasted four months and was done at no cost to the subjects. The sample collection method was based on several dental clinics, hospitals, and comprehensive urban and rural centers (health houses) in the cities of Gorgan and Gonbad. We also performed a household base survey to cover some remote rural areas of the province. Patients suspected of OPML were referred to the dental clinic for final diagnosis and followed up.
On the day of the examination, we explained the purpose of the study to the participants. Written informed consent was completed for each participant. Then, we completed a questionnaire containing demographic information and a few other questions about previous history of cancer and other maxillofacial disease. It should also be noted that this questionnaire was evaluated in an expert panel by eight experts (two assistant Professor of Biostatistics, one associate Professor of Epidemiology, one assistant Professor of Community Oral Health, two assistant Professor of Oral and Maxillofacial Surgery and two assistant Professor of Oral & Maxillofacial Medicine). We performed a pilot study on 30 patients before the primary research to check the validity and reliability of the questionnaire. The Cronbach's alpha was 80%, which was acceptable. A dentist performed examinations under the supervision of a maxillofacial specialist using different oral examination techniques (observation, palpation of the lesion) and tools such as a unit light, mirror, probe, gauze, and flashlight in the examination room(15, 16). First, an extra-oral examination was performed for each person, which included the following: a) head and neck examination: in terms of distortion or facial deformity and swelling of the face b) examination of the lymph nodes of the head and neck: in terms of size, consistency, mobility or stability, and pain, and then an intra-oral examination was performed, which included the examination of the oral mucosa, especially the areas such as the lateral and ventral surface of the tongue, the floor of the mouth, the soft palate, and the lips, where the possibility of the formation of these lesions is higher(15).
At this stage, if there was no suspicious lesion in the mouth and no risk factor, the person left the examination center and was advised to participate in oral cancer screening every five years. In the case of founding a lesion, participants were examined in terms of a) the involved area, b) size, c) color (white, red) and diffusion pattern (homogeneous, non-homogeneous), d) external border of the lesion: clear or unclear e) consistency: (soft, hard) k) surface characteristics of the lesion (granular, verrucous, wound or scar)(17).
After the final diagnosis, the lesions were divided into the following categories (15): 1) Leukoplakia, 2) Erythroplakia, 3) Erythroleukoplakia, 4) lichenoid reactions, 5) lichen planus, 6) Submucosal fibrosis, 7) Actinic cheilitis, 8) Palatal keratosis caused by reverse smoker's palate(18). For the final diagnosis, all cases of lesions were consulted with an oral and maxillofacial specialist (The questionnaire and consent letter are attached in the supplementary material).
Sample size
The sample size was estimated, assuming that the prevalence of OPML was 4%(19, 20). We used the following equation for sample size estimation where Z1-α/2= 1.96 and d was 0.01. Accordingly, the sample size was estimated to be 2305. The final estimated sample size was 2500 considering 10% drop in the study samples.
During the study, 2305 people were referred for the oral examination. Of this number, 1900 people agreed to be interviewed and filled out the questionnaire (Response rate= 75%).
Inclusion criteria were:
All people aged 40 and above who voluntarily participated in the research.
Exclusion criteria were:
People taking systemic medications that have oral side effects;
People with lupus and systemic diseases with oral complications;
People with traumatic lesions.
Statistical analysis
The statistical analysis of the data was performed by chi squared, Student t-test and One-Way ANOVA tests, and P values <0.05 were considered significant. Finally, the resulting data were analyzed using SPSS (version 22) statistical software.
Findings
1900 people participated in this study, 719 men (37.8%) and 1181 women (62.2%). The samples were in the age range of 40 to 100 years and the average age of these people was 49.5 years. The largest numbers of participants were in the age range of 40-50 years (1207 people).
Most of the women were housewives, agriculture, and self-employment were the most shared occupations between women and men.
89% of the participants did not show any risky behavior.
10.6% of the people used tobacco and 1.4% people used alcohol. Also, cigarettes were the most commonly used smoking substance, and the most common type of alcohol consumed by people was wine.
Among 1900 participants, 69 people (3.6%) had OPML lesions. The frequency of these lesions was higher in men. In women it was 3.1% of the total female population and in men it was 4.5% of the total male population. Despite this difference, no significant difference was observed between the two groups (p=0.88).
The average age of people with OPML is 54.8 ± 13.78 and it was significantly higher than healthy subjects.
Also, ethnicity had a significant relationship with the occurrence of OPML (p=0.05). In the Turkmen race, men were more susceptible than women. (p=0.01)
In Turkmen ethnicity, smoking has a direct relationship with OPML lesions (P=0.00).
The prevalence of OPML lesions has a significant relationship with the level of education; it was observed that patients with a bachelor's level of education had a higher probability of having OPML lesions than the entire population (12.7%). Also, this relationship is more common in men (p=0.00).
Smoking tobacco was the most commonly used substance in affected people (11.6%). Also, Marijuana, Snuff and Crystal meth were not used by any of the research participants (Table 1).
Table 1. The frequency of the type of Tobacco products used among people over 40 years old in Golestan province
The type of Tobacco products used by the affected person
|
The frequency of Tobacco products used in the affected person
|
The percentage of Tobacco products in the affected person
|
Opium
|
1
|
1. 4
|
Cigarettes
|
8
|
11.6
|
Hookah
|
2
|
2.9
|
Opium + Cigarettes
|
1
|
1.4
|
Cigarettes + Hookah
|
1
|
1.4
|
Also, these lesions were more common in men who used tobacco (p=0.04).
Smoking had a very important and significant role in developing OPML lesions, (p=0.01), but alcohol consumption as another risk factor had no significant relationship with OPML lesions in both genders (p=0.243).
Positive family history of oral cancer or other cancers had no significant relationship with the occurrence of OPML lesions (p=0.68). Also, this relationship did not show a significant difference in both genders (p=0.561).
OPML lesions in the tongue area were more common than other areas of the mouth (29%). After that, the most frequently observed area was the buccal mucosa (26.1%) and maxillary gingiva (8.1%) (Table 2).
Table 2. Frequency of OPML lesions in people over 40 years old by the involved area
Lesion site
|
Percentage
|
Frequency
|
Dorsal surface of tongue
|
29.0
|
20
|
Buccal mucosa
|
26.1
|
18
|
Maxillary gingiva
|
8.7
|
6
|
Upper vestibule
|
7.2
|
5
|
upper lip
|
5.8
|
4
|
floor of the mouth
|
5.8
|
4
|
Lower lip
|
4.3
|
3
|
Ventral surface of tongue
|
2.9
|
2
|
mandibular gingiva
|
2.9
|
2
|
jaw bone
|
2.9
|
2
|
toothless ridge
|
2.9
|
2
|
corners of the lips
|
1.4
|
1
|
Total
|
100.0
|
69
|
Table 3. Types of OPML lesions and the frequency of these lesions in the population of people over 40 years-old in Golestan province
OPML lesion type
|
Frequency
|
Percentage
|
Lichen planus
|
34
|
49.2
|
Suspicious to OSCC
|
13
|
18.8
|
Leukoplakia
|
10
|
14.4
|
Lichenoid reactions
|
7
|
10.1
|
Erytroplakia
|
3
|
4.3
|
Erytroleukoplakia
|
2
|
2.8
|
Actinic chelitis
|
0
|
0
|
Oral submocous fibrosis
|
0
|
0
|
Total
|
69
|
100.0
|
It was also observed that the frequency of this lesion is higher in the center of the province (Gorgan) (58%) than in other cities of the province (Figure 1).