Diabete MellitusNCT07870291
Effectiveness of a Multimodal Cognitive Rehabilitation Protocol Combined With Mechanical Periodontal Therapy in Diabetic Patients With Cognitive Impairment
A study testing Group A, Group B and Group C in people with Diabete Mellitus, run by Emad Eldin Mohamed at 1 site in Egypt.
Trial summary
Type 2 diabetes mellitus (T2DM) is strongly associated with an increased risk of cognitive impairment via multiple, converging pathways chronic hyperglycemia, insulin resistance, and vascular injury leading to deficits in memory, attention, and executive functions. Read more about this study
- Who is it for?
- Ages 50 to 60 years
- Conditions the study is for
- Diabete Mellitus
- What is being tested?
- Group A, Group B and Group C
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Feb 2026to 11 Nov 2026
- 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 50 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age from 50 to 60 years
- patients with T2DM more than 1 year; HbA1c 7-10%; moderate periodontitis; cognitive impairment (MoCA <26 adjusted for education); stable medical therapy; able to participate in moderate exercise
Who cannot join
- Diagnosed dementia
- major neurologic/psychiatric illness
- periodontal therapy or systemic antibiotics within past 6 months
- contraindications to exercise
- severe vision/hearing limits precluding testing.
Trial locations and contacts
1 site in 1 country.
About this study
Type 2 diabetes mellitus (T2DM) is strongly associated with an increased risk of cognitive impairment via multiple, converging pathways chronic hyperglycemia, insulin resistance, and vascular injury leading to deficits in memory, attention, and executive functions. Large-scale reviews and epidemiologic syntheses note high prevalence of mild cognitive impairment (MCI) in diabetes and underscore the need for targeted interventions that address metabolic and neurocognitive mechanisms simultaneously.
Read the detailed description
Type 2 diabetes mellitus (T2DM) is strongly associated with an increased risk of cognitive impairment via multiple, converging pathways chronic hyperglycemia, insulin resistance, and vascular injury leading to deficits in memory, attention, and executive functions. Large-scale reviews and epidemiologic syntheses note high prevalence of mild cognitive impairment (MCI) in diabetes and underscore the need for targeted interventions that address metabolic and neurocognitive mechanisms simultaneously.
Periodontal disease is common in T2DM and has a bidirectional relationship with glycemic control. Randomized trials and meta-analyses show that non-surgical periodontal therapy (NSPT), especially scaling and root planning (SRP), can reduce HbA1c and improve periodontal indices; several syntheses also report short-term reductions in systemic inflammatory biomarkers such as high-sensitivity C-reactive protein. Concurrently, longitudinal and systematic reviews suggest an association between poor periodontal health and cognition impairment through chronic inflammation, bacterial transmission to the brain, and reduction of nutrient intake, increasing the risk of dementia. Harmful bacteria, such as Porphyromonas gingivalis, can enter the bloodstream and travel to the brain, contributing to plaque build-up and neurodegeneration
- Conditions
- Diabete Mellitus
- Being tested
- Group A, Group B, Group C
- Keywords
- Diabetic Patients, Cognitive Impairment, Cognitive Rehabilitation Protocol
- Medical subject headings
- Diabetes Mellitus, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group AOther
multimodal cognitive rehabilitation alone
Group BOther
- Curettes and scalers
Group COther
multimodal cognitive rehabilitation in combination with mechanical periodontal therapy
| Study group | Role | What they receive |
|---|---|---|
| group A: multimodal cognitive rehabilitation | Experimental | * Adaptive cognitive training (memory, attention, processing speed, executive functions).
* Dosage: 2 sessions per week/60 minutes per session. Receives: Other: Group A |
| group B: Mechanical Periodontal Therapy | Experimental | * Curettes and scalers used to remove plaque and tartar (calculus) from tooth surfaces. Scalers are used for supra-gingival (above gum line) cleaning, while curettes feature a rounded toe for safe, effective sub-gingival (below gum line) scaling, root planning, and tissue removal
* Dosage: 2 sessions per week/60 minutes per session.
* Aerobic: 20 min.
* Balance: 10 min (tandem stance and dynamic weight shifts).
* Resistance (elastic bands): 15 min, 2sets with 10 reps for major muscle groups; progress band color/resistance every 2 weeks. Receives: Other: Group B |
| group C: multimodal cognitive rehabilitation in combination with Mechanical Periodontal Therapy | Experimental | combination programme of each group Receives: Other: Group C |
What is being measured
The primary outcome is the main question the study is designed to answer.
1- Montreal Cognitive Assessment test (MoCA)
MoCA used for measurement of Global cognition (memory, attention, language, and visuospatial skills, with a score of 26 or higher considered normal)
Measured: 12 weeks
2- Trail Making Test (TMT) Part A and B
TMT used for measurement of executive function which consists of two parts, A and B. The participant will need a pencil to perform each part.
Measured: 12 Weeks
3- Symbol Digit Modalities Test (SDMT)
SDMT used to assess information processing speed, visual scanning, tracking, and motor speed. The participants match 9 geometric symbols with corresponding digits (1-9) using a key. Participants write or speak the correct number for each symbol in a randomized sequence for 90 seconds.
Measured: 12 weeks
4- The HbA1c test
The HbA1c test measures average blood sugar levels over the past 2-3 months via a simple blood draw from a vein (or occasionally a finger prick). No fasting or special preparation is required
Measured: 12 weeks
5- A C-Reactive Protein (CRP)
CRP measures the inflammation levels in the body by collecting blood from a vein in the arm
Measured: 12 weeks
Secondary outcomes (1)
6- Oral Health-Related Quality of Life (OHRQoL)
OHRQoL used to measure the functional, social, and psychological impacts of oral conditions. Instructions require patients to rate the frequency or severity of issues (e.g., pain, chewing difficulty) over a specific period, often using Likert scales (e.g., "never" to "very often" or "always" to "never")
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start14 Feb 2026
- Primary completion25 Oct 2026 (estimated)
- Study completion11 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabete 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emad Eldin Mohamed
- Sponsor type
- University, hospital or other
- Collaborators
- Middle East University
- Responsible party
- Sponsor-investigator, Emad Eldin Mohamed, Middle East University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07870291
- Sponsor's protocol ID
- 902376
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Multimodal Cognitive Rehabilitation Protocol Combined With Mechanical Periodontal Therapy in Diabetic Patients With Cognitive Impairment
- ClinicalTrials.gov ID
- NCT07870291
- Acronym / sponsor ID
- 902376
- Conditions
- Diabete Mellitus
- Keywords
- Diabetic Patients, Cognitive Impairment, Cognitive Rehabilitation Protocol
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Emad Eldin MohamedUniversity, hospital or other
- Collaborators
- Middle East University
- Study start
- 14 Feb 2026 (actual)
- Primary completion
- 25 Oct 2026 (estimated)
- Study completion
- 11 Nov 2026 (estimated)
- First posted
- 13 Oct 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.
Type 2 diabetes mellitus (T2DM) is strongly associated with an increased risk of cognitive impairment via multiple, converging pathways chronic hyperglycemia, insulin resistance, and vascular injury leading to deficits in memory, attention, and executive functions. Large-scale reviews and epidemiologic syntheses note high prevalence of mild cognitive impairment (MCI) in diabetes and underscore the need for targeted interventions that address metabolic and neurocognitive mechanisms simultaneously.
Detailed description
Type 2 diabetes mellitus (T2DM) is strongly associated with an increased risk of cognitive impairment via multiple, converging pathways chronic hyperglycemia, insulin resistance, and vascular injury leading to deficits in memory, attention, and executive functions. Large-scale reviews and epidemiologic syntheses note high prevalence of mild cognitive impairment (MCI) in diabetes and underscore the need for targeted interventions that address metabolic and neurocognitive mechanisms simultaneously.
Periodontal disease is common in T2DM and has a bidirectional relationship with glycemic control. Randomized trials and meta-analyses show that non-surgical periodontal therapy (NSPT), especially scaling and root planning (SRP), can reduce HbA1c and improve periodontal indices; several syntheses also report short-term reductions in systemic inflammatory biomarkers such as high-sensitivity C-reactive protein. Concurrently, longitudinal and systematic reviews suggest an association between poor periodontal health and cognition impairment through chronic inflammation, bacterial transmission to the brain, and reduction of nutrient intake, increasing the risk of dementia. Harmful bacteria, such as Porphyromonas gingivalis, can enter the bloodstream and travel to the brain, contributing to plaque build-up and neurodegeneration
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group A: multimodal cognitive rehabilitation | Experimental | Other: Group A* Adaptive cognitive training (memory, attention, processing speed, executive functions). * Dosage: 2 sessions per week/60 minutes per session. |
| group B: Mechanical Periodontal Therapy | Experimental | Other: Group B* Curettes and scalers used to remove plaque and tartar (calculus) from tooth surfaces. Scalers are used for supra-gingival (above gum line) cleaning, while curettes feature a rounded toe for safe, effective sub-gingival (below gum line) scaling, root planning, and tissue removal * Dosage: 2 sessions per week/60 minutes per session. * Aerobic: 20 min. * Balance: 10 min (tandem stance and dynamic weight shifts). * Resistance (elastic bands): 15 min, 2sets with 10 reps for major muscle groups; progress band color/resistance every 2 weeks. |
| group C: multimodal cognitive rehabilitation in combination with Mechanical Periodontal Therapy | Experimental | Other: Group Ccombination programme of each group |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age from 50 to 60 years
- patients with T2DM more than 1 year; HbA1c 7-10%; moderate periodontitis; cognitive impairment (MoCA <26 adjusted for education); stable medical therapy; able to participate in moderate exercise
Key exclusion criteria (5 listed)
- Diagnosed dementia
- major neurologic/psychiatric illness
- periodontal therapy or systemic antibiotics within past 6 months
- contraindications to exercise
- severe vision/hearing limits precluding testing.
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 |
|---|---|---|
| Group Amultimodal cognitive rehabilitation alone | Other | group A: multimodal cognitive rehabilitation |
| Group B• Curettes and scalers | Other | group B: Mechanical Periodontal Therapy |
| Group Cmultimodal cognitive rehabilitation in combination with mechanical periodontal therapy | Other | group C: multimodal cognitive rehabilitation in combination with Mechanical Periodontal Therapy |
Primary outcome
1- Montreal Cognitive Assessment test (MoCA)
Time frame: 12 weeks
MoCA used for measurement of Global cognition (memory, attention, language, and visuospatial skills, with a score of 26 or higher considered normal)
2- Trail Making Test (TMT) Part A and B
Time frame: 12 Weeks
TMT used for measurement of executive function which consists of two parts, A and B. The participant will need a pencil to perform each part.
3- Symbol Digit Modalities Test (SDMT)
Time frame: 12 weeks
SDMT used to assess information processing speed, visual scanning, tracking, and motor speed. The participants match 9 geometric symbols with corresponding digits (1-9) using a key. Participants write or speak the correct number for each symbol in a randomized sequence for 90 seconds.
4- The HbA1c test
Time frame: 12 weeks
The HbA1c test measures average blood sugar levels over the past 2-3 months via a simple blood draw from a vein (or occasionally a finger prick). No fasting or special preparation is required
5- A C-Reactive Protein (CRP)
Time frame: 12 weeks
CRP measures the inflammation levels in the body by collecting blood from a vein in the arm
1 secondary outcome
6- Oral Health-Related Quality of Life (OHRQoL)
Time frame: 12 weeks
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 15 Oct 2026.
- Individual participant dataSharing planned: No
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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 Group A, Group B and Group C in people with Diabete Mellitus, run by Emad Eldin Mohamed 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 2 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 15 Oct 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 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. 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?
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?
1- Montreal Cognitive Assessment test (MoCA) (time frame: 12 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Oct 2026.