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Active, not recruitingNCT07870291Updated Oct 15, 2026

Effectiveness of a Multimodal Cognitive Rehabilitation Protocol Combined With Mechanical Periodontal Therapy in Diabetic Patients With Cognitive Impairment

An interventional study of Group A and Group B in Diabete Mellitus, sponsored by Emad Eldin Mohamed. Active, not recruiting at 1 site in Egypt. Open to participants aged 50 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-10-15.

Sponsored by Emad Eldin Mohamed · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Feb 2026, registered Oct 2026).
Updated Oct 13, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
105
Allocation
Randomized
Ages
50 Years to 60 Years
Sex
All
01

Study 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. 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

02

Conditions studied

  • Diabete Mellitus

Keywords

  • Diabetic Patients
  • Cognitive Impairment
  • Cognitive Rehabilitation Protocol
03

In context

Diabetes Mellitus

11,089 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 105 is above the median of 80 across 8,491 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Emad Eldin Mohamed is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age from 50 to 60 years
  2. 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

Exclusion criteria

Exclusion Criteria:

  1. Diagnosed dementia
  2. major neurologic/psychiatric illness
  3. periodontal therapy or systemic antibiotics within past 6 months
  4. contraindications to exercise
  5. severe vision/hearing limits precluding testing.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
105 participants (actual)

Study arms

  • Experimental
    group A: multimodal cognitive rehabilitation

    * Adaptive cognitive training (memory, attention, processing speed, executive functions). * Dosage: 2 sessions per week/60 minutes per session.

    Other: Group A

  • Experimental
    group B: Mechanical Periodontal Therapy

    * 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.

    Other: Group B

  • Experimental
    group C: multimodal cognitive rehabilitation in combination with Mechanical Periodontal Therapy

    combination programme of each group

    Other: Group C

Interventions

  • OtherGroup A

    multimodal cognitive rehabilitation alone

  • OtherGroup B

    • Curettes and scalers

  • OtherGroup C

    multimodal cognitive rehabilitation in combination with mechanical periodontal therapy

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: 12 weeks

  2. 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.

    Time frame: 12 Weeks

  3. 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.

    Time frame: 12 weeks

  4. 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

    Time frame: 12 weeks

  5. 5- A C-Reactive Protein (CRP)

    CRP measures the inflammation levels in the body by collecting blood from a vein in the arm

    Time frame: 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")

    Time frame: 12 weeks

07

Study locations

1 site
  • Bassam Ahmed Nabil
    October City, Cairo Governorate 78345, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2026 (actual). Primary completion is estimated for Oct 2026, 8 months after the start.

Of 2,196 non-industry interventional studies with no phase under Diabetes Mellitus, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 38. This study's planned 8 months is below that.

Counting every sponsor, half of 2,388 studies reached it within 20 months; a quarter within 9 and three quarters within 37.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 6, 2026
First posted
Oct 13, 2026
StartActual
Feb 14, 2026
Primary completionEst.
Oct 25, 2026
CompletionEst.
Nov 11, 2026
Last update
Oct 15, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 13, 2026
Show all 2 updates
  1. Oct 15, 2026
    Minor edits only
    + 2 other changes: index terms and conditions
  2. Oct 13, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07870291
Lead sponsor
Emad Eldin Mohamed
Collaborators
Middle East University
Responsible party
Emad Eldin Mohamed (associate professor, Middle East University) — Sponsor-investigator
First posted
Oct 13, 2026
Start date
Feb 14, 2026
Primary completion
Oct 25, 2026 (estimated)
Completion
Nov 11, 2026 (estimated)
Last update
Oct 15, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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