XerostomiaNCT06703372
Photobiomodulation In Treatment Of Xerostomia In Type Ii Diabetic Patients
A study testing Diode Laser 980 nm, 0.2W in people with Xerostomia and Diabetes Mellitus, run by Hams Hamed Abdelrahman at 1 site in Egypt.
Trial summary
Xerostomia is a major oral health problem that if not recognized and treated can have a significant effect on a patient's quality of life. It leads to difficulties with speech, swallowing and taste alteration. Pathological causes of xerostomia are divided into local and systemic factors. Read more about this study
- Who is it for?
- Ages 25 to 50 years
- Conditions the study is for
- Xerostomia, Diabetes Mellitus
- What is being tested?
- Diode Laser 980 nm, 0.2W
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Oct 2022to 1 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with type 2 diabetes mellitus suffering from xerostomia and on oral hypoglycemic drugs.
- Glycated hemoglobin less than 7%.
- Duration of diabetes mellitus not less than 4 years and not more than 8 years
Who cannot join
- Patients receiving any drugs that cause hyposalivation.
- Patients with any systemic disease reported to produce hyposalivation (sjogren's syndrome, hepatitis c, rheumatoid arthritis and lupus erythematosus).
- Patients receiving chemotherapy and radiotherapy.
- Individuals with skin lesions in the treatment zone to avoid any complications occurring in this area by laser exposure
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Outpatient Clinic of Oral medicine Department, Faculty of Dentistry, Alexandria University, Egypt
Alexandria
About this study
Official title: Effectiveness Of Photobiomodulation In Treatment Of Xerostomia In Type Ii Diabetic Patients (A Randomized, Controlled Clinical Trial)
Xerostomia is a major oral health problem that if not recognized and treated can have a significant effect on a patient's quality of life. It leads to difficulties with speech, swallowing and taste alteration. Pathological causes of xerostomia are divided into local and systemic factors. Local factors include smoking, salivary gland diseases and head and neck radiation therapy. Systemic factors include autoimmune diseases as Sjögren syndrome and hormonal disorders as Diabetes Mellitus. Photobiomodulation (PBM) previously known as Low Level Laser Therapy (LLLT) is the application of red and near infra-red light over injuries or lesions to improve wound and soft tissue healing, reduce inflammation and give relief for both acute and chronic pain. It also has grabbed the attention over the last few years as an effective treatment for xerostomia.
- Conditions
- Xerostomia, Diabetes Mellitus
- Being tested
- Diode Laser 980 nm, 0.2W, Placebo Diode laser
- Medical subject headings
- Xerostomia, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diode Laser 980 nm, 0.2WOther
diode laser will be used at an operating wavelength of 980 nm, with adoption of the due safety measures in all cases. Laser irradiation will be applied bilaterally to the skin over the area of the submandibular and parotid glands. Irradiation will be applied externally to the parotid gland on a continuous basis and likewise to the submandibular gland moving the laser very slowly over the gland zone
Placebo Diode laserOther
the tip of the instrument will be sealed with blue rubber to prevent the passage of light
| Study group | Role | What they receive |
|---|---|---|
| Diode laser | Experimental | Not described Receives: Other: Diode Laser 980 nm, 0.2W |
| placebo diode laser | Placebo comparator | Not described Receives: Other: Placebo Diode laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in severity of xerostomia
Summated Xerostomia Inventory-Dutch Version questionnaire (SXI-D) version will be used to assess the severity of xerostomia.
Questions:
- My mouth feels dry when eating a meal.
- My mouth feels dry.
- I have difficulty in eating dry foods.
- I have difficulties swallowing certain foods.
- My lips feel dry
Scores:
- Never scoring 1
- Occasionally scoring 2
- Ever scoring 3
Measured: baseline, 2 weeks, 4 weeks, 6 weeks and 12 weeks
Change in unstimulated salivary flow rate
Hypo-salivation will be determined if the unstimulated salivary flow rate is 0.1- 0.2 ml/min or less
Measured: baseline, 2 weeks, 4 weeks, 6 weeks and 12 weeks
Change in stimulated salivary flow rate
Whole-mouth SFR measurement will be conducted at every follow-up time point.
Measured: baseline, 2 weeks, 4 weeks, 6 weeks and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2024
- Study start20 Oct 2022
- Primary completion1 Aug 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for XerostomiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hams Hamed Abdelrahman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hams Hamed Abdelrahman, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06703372
- Sponsor's protocol ID
- 0404-9/22
- Status last verified
- Nov 2024
- First submitted
- 21 Nov 2024
- Last updated
- 25 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ali HA, Attia NS, Zaki AM, Gaweesh YY. Effectiveness of photobiomodulation in the treatment of xerostomia in type II diabetic patients. Odontology. 2026 Jul 20. doi: 10.1007/s10266-026-01493-2. Online ahead of print.
PubMed 42474921
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness Of Photobiomodulation In Treatment Of Xerostomia In Type Ii Diabetic Patients (A Randomized, Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT06703372
- Acronym / sponsor ID
- 0404-9/22
- Conditions
- Xerostomia, Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hams Hamed AbdelrahmanUniversity, hospital or other
- Study start
- 20 Oct 2022 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 25 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Xerostomia is a major oral health problem that if not recognized and treated can have a significant effect on a patient's quality of life. It leads to difficulties with speech, swallowing and taste alteration. Pathological causes of xerostomia are divided into local and systemic factors. Local factors include smoking, salivary gland diseases and head and neck radiation therapy. Systemic factors include autoimmune diseases as Sjögren syndrome and hormonal disorders as Diabetes Mellitus. Photobiomodulation (PBM) previously known as Low Level Laser Therapy (LLLT) is the application of red and near infra-red light over injuries or lesions to improve wound and soft tissue healing, reduce inflammation and give relief for both acute and chronic pain. It also has grabbed the attention over the last few years as an effective treatment for xerostomia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diode laser | Experimental | Other: Diode Laser 980 nm, 0.2W |
| placebo diode laser | Placebo comparator | Other: Placebo Diode laser |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients with type 2 diabetes mellitus suffering from xerostomia and on oral hypoglycemic drugs.
- Glycated hemoglobin less than 7%.
- Duration of diabetes mellitus not less than 4 years and not more than 8 years
Key exclusion criteria (4 listed)
- Patients receiving any drugs that cause hyposalivation.
- Patients with any systemic disease reported to produce hyposalivation (sjogren's syndrome, hepatitis c, rheumatoid arthritis and lupus erythematosus).
- Patients receiving chemotherapy and radiotherapy.
- Individuals with skin lesions in the treatment zone to avoid any complications occurring in this area by laser exposure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diode Laser 980 nm, 0.2Wdiode laser will be used at an operating wavelength of 980 nm, with adoption of the due safety measures in all cases. Laser irradiation will be applied bilaterally to the skin over the area of the submandibular and parotid glands. Irradiation will be applied externally to the parotid gland on a continuous basis and likewise to the submandibular gland moving the laser very slowly over the gland zone | Other | Diode laser |
| Placebo Diode laserthe tip of the instrument will be sealed with blue rubber to prevent the passage of light | Other | placebo diode laser |
Primary outcome
Change in severity of xerostomia
Time frame: baseline, 2 weeks, 4 weeks, 6 weeks and 12 weeks
Summated Xerostomia Inventory-Dutch Version questionnaire (SXI-D) version will be used to assess the severity of xerostomia. Questions: * My mouth feels dry when eating a meal. * My mouth feels dry. * I have difficulty in eating dry foods. * I have difficulties swallowing certain foods. * My lips feel dry Scores: * Never scoring 1 * Occasionally scoring 2 * Ever scoring 3
Change in unstimulated salivary flow rate
Time frame: baseline, 2 weeks, 4 weeks, 6 weeks and 12 weeks
Hypo-salivation will be determined if the unstimulated salivary flow rate is 0.1- 0.2 ml/min or less
Change in stimulated salivary flow rate
Time frame: baseline, 2 weeks, 4 weeks, 6 weeks and 12 weeks
Whole-mouth SFR measurement will be conducted at every follow-up time point.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
- Derived from this study: PubMed 42474921Ali HA, Attia NS, Zaki AM, Gaweesh YY. Effectiveness of photobiomodulation in the treatment of xerostomia in type II diabetic patients. Odontology. 2026 Jul 20. doi: 10.1007/s10266-026-01493-2. Online ahead of print.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diode Laser 980 nm, 0.2W in people with Xerostomia and Diabetes Mellitus, run by Hams Hamed Abdelrahman at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in severity of xerostomia (time frame: baseline, 2 weeks, 4 weeks, 6 weeks and 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06703372, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2024.