Diabetes MellitusIOCIDNCT07425275
Integrated Oral Care Intervention for Xerostomia in Diabetes Patients
A study testing Integrated Oral Care Intervention in people with Diabetes Mellitus and Diabetic Neuropathies, run by Khyber Medical University Peshawar at 1 site in Pakistan.
Trial summary
Diabetes patients commonly experience dry mouth also known as xerostomia which can affect eating speaking oral health and overall quality of life. This study evaluates whether simple oral care actions delivered by endocrinologists during routine diabetes clinic visits can improve dry mouth symptoms and oral health… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Diabetes Mellitus, Diabetic Neuropathies
- What is being tested?
- Integrated Oral Care Intervention
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Aug 2026to 30 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Presence of a single stone in the renal pelvis.
- Age less than 18 years.
- No congenital or acquired urinary tract abnormalities.
- No pre-existing chest diseases (e.g., chronic lung disease, pleural effusion).
Who cannot join
- Patients with multiple kidney stones.
- Calyceal stones (stones located specifically in a calyx).
- Pelviureteric junction obstruction (PUJO).
- Pelvic kidney (renal ectopia).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Lady Reading Hospital
Peshawar, KPK, 25000
Dr Mahdia Babak, MPH, +92 331 0066683, mahdia.iph@kmu.edu.pk
About this study
Official title: The Impact of Integrated Oral Care Intervention Provided by Endocrinologists on Oral Health and Well-being in Diabetes Patients
Diabetes patients commonly experience dry mouth also known as xerostomia which can affect eating speaking oral health and overall quality of life. This study evaluates whether simple oral care actions delivered by endocrinologists during routine diabetes clinic visits can improve dry mouth symptoms and oral health related quality of life. Endocrinologists will be trained to screen for dry mouth provide brief counseling prescribe saliva substitutes and refer patients to dental services when needed. Adult patients with diabetes and symptoms of dry mouth will be followed before and after the intervention to assess changes in xerostomia severity and oral health outcomes. The study will also explore barriers and facilitators to integrating oral health care into routine diabetes management in Pakistan.
Read the detailed description
This mixed methods pre post implementation study aims to assess the effectiveness and feasibility of integrating basic oral health care into routine diabetes management. Diabetes related xerostomia is a common but under addressed condition that increases the risk of dental caries periodontal disease oral infections and reduced quality of life. In low and middle income settings access to dental care is limited and endocrinologists often serve as the primary point of contact for diabetes patients.
In this study endocrinologists at Khyber Medical University affiliated hospitals will receive structured training on oral health screening counseling prescription of saliva substitutes and referral pathways to dental services. Adult patients with type 1 or type 2 diabetes who report symptoms of dry mouth will be enrolled through consecutive sampling during outpatient clinic visits.
The intervention includes four core components screening counseling prescribing topical saliva substitutes and referral to dental care. Outcomes will be assessed at baseline and follow up using validated tools including the Xerostomia Inventory and the Oral Health Impact Profile 14. Oral health status will also be assessed using the Oral Health Assessment Tool. Implementation outcomes such as reach adoption fidelity and acceptability will be evaluated using the RE AIM framework while contextual barriers and facilitators will be explored through interviews guided by the Consolidated Framework for Implementation Research.
The findings will provide evidence on the clinical effectiveness and implementation feasibility of endocrinologist delivered oral care interventions and will inform policy recommendations for integrating oral health into non communicable disease services in Pakistan.
- Conditions
- Diabetes Mellitus, Diabetic Neuropathies
- Being tested
- Integrated Oral Care Intervention
- Keywords
- Diabetes mellitus, Oral health quality of life, Non communicable diseases, Integrated oral care
- Medical subject headings
- Diabetes Mellitus, Diabetic Neuropathies, Noncommunicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated Oral Care InterventionProcedure or surgery
Also called Endocrinologist delivered oral care, Xerostomia management intervention, Integrated oral health care in diabetes
The integrated oral care intervention consists of a structured set of oral health actions delivered by trained endocrinologists during routine diabetes clinic visits. The intervention includes screening for xerostomia using a brief screening question followed by the Xerostomia Inventory for participants who screen positive. A focused oral examination is performed to identify signs of oral dryness and related oral health problems. Participants receive brief counseling on oral hydration strategies oral hygiene practices use of fluoride products and lifestyle measures to relieve dry mouth symptoms. Topical saliva substitute products such as sprays or gels are prescribed when indicated. Participants are also referred to dental services for further evaluation and management when clinically required. The intervention is delivered to all participants and outcomes are assessed before and after the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Integrated Oral Care Intervention | Experimental | Participants in this arm will receive an integrated oral care intervention delivered by trained endocrinologists during routine diabetes clinic visits. The intervention includes screening for xerostomia using a brief screening question and the Xerostomia Inventory, oral examination for signs of dry mouth, brief counseling on oral hydration and oral hygiene practices, prescription of topical saliva substitute products as needed, and referral to dental services for further evaluation and management. Outcomes will be assessed at baseline and at follow up to evaluate changes in xerostomia severity and oral health related quality of life. Receives: Procedure: Integrated Oral Care Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Xerostomia Severity Score
Change in xerostomia severity measured using the Xerostomia Inventory-11 (XI-11) questionnaire, comparing baseline and post-intervention scores. The XI-11 score ranges from 11 to 55, with higher scores indicating greater severity of dry mouth.
Measured: Baseline to 2 months after intervention
Change in Oral Health-Related Quality of Life
Change in oral health-related quality of life assessed using the Oral Health Impact Profile-14 (OHIP-14), comparing baseline and post-intervention scores. Total score ranges from 0 to 56, with higher scores indicating poorer quality of life.
Measured: Baseline to 2 months after intervention
Secondary outcomes (2)
Change in Clinical Oral Health Status
Change in oral health status assessed using the Oral Health Assessment Tool (OHAT), evaluating eight oral health domains. Higher total scores indicate poorer oral health.
Measured: Baseline to 2 months after intervention
Provider Adoption and Implementation Fidelity
Assessment of endocrinologist adherence to the integrated oral-care intervention protocol using structured fidelity checklists and training evaluation tools.
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start1 Aug 2026
- Primary completion25 Dec 2026 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single arm pre post interventional study. All enrolled participants will receive the integrated oral care intervention delivered by trained endocrinologists. Outcomes will be measured at baseline and again after the intervention to assess changes in xerostomia severity and oral health related quality of life.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Khyber Medical University Peshawar
- Sponsor type
- University, hospital or other
- Collaborators
- Khyber Teaching Hospital
- Responsible party
- Sponsor
- Investigators
- Dr. Mahdia Babak, BDS, MPH, Principal investigator, Institute of Public Health, Khyber Medical University (KMU), Peshawar, PakistanDr. Zohaib Khan, Study director, Director ORIC, KMUDr. Mohammad Jawad, MBBS, MCPS, Principal investigator, Khyber Medical University, Peshawar, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07425275
- Sponsor's protocol ID
- KMU/DIR/CTU/2025/011
- Acronym
- IOCID
- Status last verified
- Aug 2026
- First submitted
- 16 Feb 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD), including baseline characteristics, outcome measures (Xerostomia Inventory-11, OHIP-14, and OHAT scores), and statistical analysis results, will be shared with qualified researchers upon reasonable request, following publication of the primary study findings. All shared data will be anonymized to ensure participant confidentiality.
Publications
Singh A, Shadangi S, Gupta PK, Rana S. Type 2 Diabetes Mellitus: A Comprehensive Review of Pathophysiology, Comorbidities, and Emerging Therapies. Compr Physiol. 2025 Feb;15(1):e70003. doi: 10.1002/cph4.70003.
PubMed 39980164Olfson M, King M, Schoenbaum M. Antipsychotic treatment of adults in the United States. J Clin Psychiatry. 2015 Oct;76(10):1346-53. doi: 10.4088/JCP.15m09863.
PubMed 26528641Fox PC, van der Ven PF, Sonies BC, Weiffenbach JM, Baum BJ. Xerostomia: evaluation of a symptom with increasing significance. J Am Dent Assoc. 1985 Apr;110(4):519-25. doi: 10.14219/jada.archive.1985.0384.
PubMed 3858368Huang S, Zeng X, Deng S, He S, Liu F. Prevalence of xerostomia in patients with type 2 diabetes mellitus: a systematic review and meta-analysis. BMC Oral Health. 2025 Apr 29;25(1):662. doi: 10.1186/s12903-025-05992-6.
PubMed 40301819
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Integrated Oral Care Intervention Provided by Endocrinologists on Oral Health and Well-being in Diabetes Patients
- ClinicalTrials.gov ID
- NCT07425275
- Acronym / sponsor ID
- IOCID / KMU/DIR/CTU/2025/011
- Conditions
- Diabetes Mellitus, Diabetic Neuropathies
- Keywords
- Diabetes mellitus, Oral health quality of life, Non communicable diseases, Integrated oral care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Khyber Medical University PeshawarUniversity, hospital or other
- Collaborators
- Khyber Teaching Hospital
- Study start
- 1 Aug 2026 (actual)
- Primary completion
- 25 Dec 2026 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 20 Feb 2026 (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.
Diabetes patients commonly experience dry mouth also known as xerostomia which can affect eating speaking oral health and overall quality of life. This study evaluates whether simple oral care actions delivered by endocrinologists during routine diabetes clinic visits can improve dry mouth symptoms and oral health related quality of life. Endocrinologists will be trained to screen for dry mouth provide brief counseling prescribe saliva substitutes and refer patients to dental services when needed. Adult patients with diabetes and symptoms of dry mouth will be followed before and after the intervention to assess changes in xerostomia severity and oral health outcomes. The study will also explore barriers and facilitators to integrating oral health care into routine diabetes management in Pakistan.
Detailed description
This mixed methods pre post implementation study aims to assess the effectiveness and feasibility of integrating basic oral health care into routine diabetes management. Diabetes related xerostomia is a common but under addressed condition that increases the risk of dental caries periodontal disease oral infections and reduced quality of life. In low and middle income settings access to dental care is limited and endocrinologists often serve as the primary point of contact for diabetes patients.
In this study endocrinologists at Khyber Medical University affiliated hospitals will receive structured training on oral health screening counseling prescription of saliva substitutes and referral pathways to dental services. Adult patients with type 1 or type 2 diabetes who report symptoms of dry mouth will be enrolled through consecutive sampling during outpatient clinic visits.
The intervention includes four core components screening counseling prescribing topical saliva substitutes and referral to dental care. Outcomes will be assessed at baseline and follow up using validated tools including the Xerostomia Inventory and the Oral Health Impact Profile 14. Oral health status will also be assessed using the Oral Health Assessment Tool. Implementation outcomes such as reach adoption fidelity and acceptability will be evaluated using the RE AIM framework while contextual barriers and facilitators will be explored through interviews guided by the Consolidated Framework for Implementation Research.
The findings will provide evidence on the clinical effectiveness and implementation feasibility of endocrinologist delivered oral care interventions and will inform policy recommendations for integrating oral health into non communicable disease services in Pakistan.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single arm pre post interventional study. All enrolled participants will receive the integrated oral care intervention delivered by trained endocrinologists. Outcomes will be measured at baseline and again after the intervention to assess changes in xerostomia severity and oral health related quality of life.
| Arm | Type | Receives |
|---|---|---|
| Integrated Oral Care Intervention | Experimental | Procedure: Integrated Oral Care InterventionParticipants in this arm will receive an integrated oral care intervention delivered by trained endocrinologists during routine diabetes clinic visits. The intervention includes screening for xerostomia using a brief screening question and the Xerostomia Inventory, oral examination for signs of dry mouth, brief counseling on oral hydration and oral hygiene practices, prescription of topical saliva substitute products as needed, and referral to dental services for further evaluation and management. Outcomes will be assessed at baseline and at follow up to evaluate changes in xerostomia severity and oral health related quality of life. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Presence of a single stone in the renal pelvis.
- Age less than 18 years.
- No congenital or acquired urinary tract abnormalities.
- No pre-existing chest diseases (e.g., chronic lung disease, pleural effusion).
Key exclusion criteria (4 listed)
- Patients with multiple kidney stones.
- Calyceal stones (stones located specifically in a calyx).
- Pelviureteric junction obstruction (PUJO).
- Pelvic kidney (renal ectopia).
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 |
|---|---|---|
| Integrated Oral Care InterventionAlso: Endocrinologist delivered oral care, Xerostomia management intervention, Integrated oral health care in diabetesThe integrated oral care intervention consists of a structured set of oral health actions delivered by trained endocrinologists during routine diabetes clinic visits. The intervention includes screening for xerostomia using a brief screening question followed by the Xerostomia Inventory for participants who screen positive. A focused oral examination is performed to identify signs of oral dryness and related oral health problems. Participants receive brief counseling on oral hydration strategies oral hygiene practices use of fluoride products and lifestyle measures to relieve dry mouth symptoms. Topical saliva substitute products such as sprays or gels are prescribed when indicated. Participants are also referred to dental services for further evaluation and management when clinically required. The intervention is delivered to all participants and outcomes are assessed before and after the intervention. | Procedure or surgery | Integrated Oral Care Intervention |
Primary outcome
Change in Xerostomia Severity Score
Time frame: Baseline to 2 months after intervention
Change in xerostomia severity measured using the Xerostomia Inventory-11 (XI-11) questionnaire, comparing baseline and post-intervention scores. The XI-11 score ranges from 11 to 55, with higher scores indicating greater severity of dry mouth.
Change in Oral Health-Related Quality of Life
Time frame: Baseline to 2 months after intervention
Change in oral health-related quality of life assessed using the Oral Health Impact Profile-14 (OHIP-14), comparing baseline and post-intervention scores. Total score ranges from 0 to 56, with higher scores indicating poorer quality of life.
2 secondary outcomes
Change in Clinical Oral Health Status
Time frame: Baseline to 2 months after intervention
Provider Adoption and Implementation Fidelity
Time frame: Baseline to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Background: PubMed 39980164Singh A, Shadangi S, Gupta PK, Rana S. Type 2 Diabetes Mellitus: A Comprehensive Review of Pathophysiology, Comorbidities, and Emerging Therapies. Compr Physiol. 2025 Feb;15(1):e70003. doi: 10.1002/cph4.70003.
- Background: PubMed 26528641Olfson M, King M, Schoenbaum M. Antipsychotic treatment of adults in the United States. J Clin Psychiatry. 2015 Oct;76(10):1346-53. doi: 10.4088/JCP.15m09863.
- Background: PubMed 3858368Fox PC, van der Ven PF, Sonies BC, Weiffenbach JM, Baum BJ. Xerostomia: evaluation of a symptom with increasing significance. J Am Dent Assoc. 1985 Apr;110(4):519-25. doi: 10.14219/jada.archive.1985.0384.
- Background: PubMed 40301819Huang S, Zeng X, Deng S, He S, Liu F. Prevalence of xerostomia in patients with type 2 diabetes mellitus: a systematic review and meta-analysis. BMC Oral Health. 2025 Apr 29;25(1):662. doi: 10.1186/s12903-025-05992-6.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD), including baseline characteristics, outcome measures (Xerostomia Inventory-11, OHIP-14, and OHAT scores), and statistical analysis results, will be shared with qualified researchers upon reasonable request, following publication of the primary study findings. All shared data will be anonymized to ensure participant confidentiality.
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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.
Dr. Mahdia Babak, BDS, MPH principal investigator
Institute of Public Health, Khyber Medical University (KMU), Peshawar, Pakistan
Dr. Zohaib Khan study director
Director ORIC, KMU
Dr. Mohammad Jawad, MBBS, MCPS principal investigator
Khyber Medical University, Peshawar, Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated Oral Care Intervention in people with Diabetes Mellitus and Diabetic Neuropathies, run by Khyber Medical University Peshawar at 1 site in Pakistan.
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 4 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: looking for participants now, as of the sponsor's last update on 18 Aug 2026. 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 Pakistan. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr Mahdia Babak, BDS, MPH (+92 331 0066683, mahdia.iph@kmu.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Xerostomia Severity Score (time frame: Baseline to 2 months after intervention). The study lists 2 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 NCT07425275, which also lists 4 linked publications.
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 18 Aug 2026.