Sialolithiasis ? Epidemiology and Pathogenesis

Obstructive salivary gland diseases ? pathogenesis, oral implications and evaluation on endoscopic guided diagnostic and treatment in preserving the salivary gland and salivary gland function

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN78711142

Enrollment

200

Registered

2012-10-17

Start date

2012-05-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sialolithiasis Digestive System Sialolithiasis

Interventions

The patients group will undergo sialendoscopy or if sialendoscopy is not an option: surgical removal of the submandibular gland, sialometry, blood samples, questionnaire and salivary gland scintigraph

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with salivary gland stones subscribed for primary sialendoscopy or if sialendoscopy is not an option extirpation of submandibular gland. For the patients to undergo sialendoscopy stone must be verified by ultrasound examination or typical symptomatology.

Exclusion criteria

Exclusion criteria: 1. Age <18 years 2. Pregnancy, lactation 3. Continuous antibiotic treatment 4. Known stenosis 5. Use of mouth washes 6. Immunosuppressive therapy 7. HIV patients 8. Sjoegren's disease 9. Previous sialendoscopy

Design outcomes

Primary

Measure	Time frame
1. Sialometry (flow and chemical composition of saliva) - The patients are examined approximately 2 weeks (pre-operative examination) before the operation and approximately 3 month after (post-operative examination). The pre- and postoperative flow and the chemical composition of the saliva will be compared. Futhermore the chemical composition of the saliva will be compared to the control group. 2. The bacterial growth in salivary gland stones, salivary gland tissue and saliva will be examined after the tissue have been fixated approximately 1 week after operation.	—

Measure

Time frame

1. Sialometry (flow and chemical composition of saliva) - The patients are examined approximately 2 weeks (pre-operative examination) before the operation and approximately 3 month after (post-operative examination). The pre- and postoperative flow and the chemical composition of the saliva will be compared. Futhermore the chemical composition of the saliva will be compared to the control group. 2. The bacterial growth in salivary gland stones, salivary gland tissue and saliva will be examined after the tissue have been fixated approximately 1 week after operation.

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Secondary

Measure	Time frame
1. To evaluate the effects of the sialendoscopy by comparing pre and post-operative salivary gland scintigraphy, and comparing pre- and postoperative saliva flow. 2. Subjective benefit from endoscopic treatment will be assessed 3 month post-operative by different questionnaires including quality of life assessment 3. Salivary gland scintigraphy 4. Blood samples from the patient will be taken 2 weeks before operation and compared to known values of parathyroid hormone (PTH) and calcium (Ca).	—

Measure

Time frame

1. To evaluate the effects of the sialendoscopy by comparing pre and post-operative salivary gland scintigraphy, and comparing pre- and postoperative saliva flow. 2. Subjective benefit from endoscopic treatment will be assessed 3 month post-operative by different questionnaires including quality of life assessment 3. Salivary gland scintigraphy 4. Blood samples from the patient will be taken 2 weeks before operation and compared to known values of parathyroid hormone (PTH) and calcium (Ca).

—

Countries

Denmark

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026