How gum treatment may help improve blood sugar control in people with type 2 diabetes
| ISRCTN | ISRCTN12954826 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12954826 |
| Sponsor | University of Medicine Tirana |
| Funder | Investigator initiated and funded |
- Submission date
- 14/01/2026
- Registration date
- 20/01/2026
- Last edited
- 20/01/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Periodontal disease and type 2 diabetes mellitus (T2DM) are two highly prevalent chronic conditions that share common inflammatory and metabolic pathways. Scientific evidence has demonstrated a bidirectional relationship between these conditions, whereby poor glycaemic control may exacerbate periodontal inflammation, and periodontal infection may negatively influence systemic metabolic control. The aim of the present randomized controlled clinical study is to evaluate the effect of non-surgical periodontal therapy on metabolic parameters in patients diagnosed with T2DM. Specifically, the study aims to determine whether improvements in periodontal status result in measurable changes in glycaemic control and systemic inflammatory markers over a 6-month follow-up period.
Who can participate?
Adults aged between 18 and 70 years diagnosed with type 2 diabetes mellitus and presenting with periodontitis are eligible to participate. Participants must have a minimum of 10 natural teeth (excluding third molars) and meet the predefined periodontal and metabolic inclusion criteria.
Individuals are excluded if they have received recent periodontal therapy or antibiotics lately, present with systemic conditions that may interfere with periodontal healing, are pregnant or breastfeeding, or are unable to attend scheduled follow-up visits.
What does the study involve?
Participants enrolled in the study undergo an initial clinical and laboratory assessment at baseline, followed by follow-up evaluations at 3 and 6 months. After baseline assessment, participants are randomly assigned to one of two parallel groups: (a) A control group, receiving standardized oral hygiene instructions and motivation, (b) A treatment group, receiving non-surgical periodontal therapy in addition to oral hygiene instructions. At each visit, periodontal clinical parameters and laboratory measurements related to glycaemic control and systemic inflammation are recorded. All procedures are conducted according to standardized clinical protocols by a calibrated examiner.
What are the possible benefits and risks of participating?
Participants may benefit from comprehensive periodontal evaluation, close clinical monitoring, and, for those in the treatment group, active periodontal therapy. Participants in the control group are offered periodontal treatment at the conclusion of the study period.
The risks associated with participation are minimal and primarily related to routine periodontal procedures, such as temporary discomfort, dentinal hypersensitivity, or mild gingival inflammation. No experimental drugs or invasive medical procedures are involved.
Where is the study run from?
University of Medicine Tirana (Albania)
When is the study starting and how long is it expected to run for?
Participant recruitment began in June 2024. Follow-up assessments are conducted over a 6-month period for each participant. Data collection is expected to be completed in March 2026, in accordance with the predefined study protocol.
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Besian Abazi, abazi.besian@gmail.com
Contact information
Principal investigator, Scientific, Public
Tirana
Tirana
1000
Albania
 ORCID ID |
0000-0003-4976-4362 |
|---|---|
| Phone | +355 674171777 |
| abazi.besian@gmail.com |
Study information
| Primary study design | Interventional | |
|---|---|---|
| Allocation | Randomized controlled trial | |
| Masking | Open (masking not used) | |
| Control | Active | |
| Assignment | Parallel | |
| Purpose | Prevention, Screening, Treatment | |
| Participant information sheet | 48840 PIS (Albanian) FRM_3_Informacion për pjesëmarrjen ne kërkim shkencor te pacientit.pdf | |
| Scientific title | Effect of non-surgical periodontal therapy on diabetes mellitus | |
| Study objectives | The primary objective of this study is to evaluate the effect of non-surgical periodontal therapy on glycaemic control in patients with type 2 diabetes mellitus, as measured by changes in HbA1c over a 6-month period. | |
| Ethics approval(s) |
Approved 22/02/2024, Council of Ethics of the University of Medicine of Tirana (Rr.e Dibres, Tirana, 1000, Albania; -; info@umed.edu.al), ref: Vendimi nr.8, 22.02.2024 | |
| Health condition(s) or problem(s) studied | Whether non-surgical periodontal therapy can improve glycemic control and systemic inflammation in patients with type 2 diabetes mellitus by reducing periodontal inflammation. | |
| Intervention | The intervention consists of non-surgical periodontal therapy, including full-mouth scaling and root planing performed using manual and/or ultrasonic instruments, combined with standardized oral hygiene instructions. Periodontal re-evaluation and supportive periodontal therapy are conducted at 3 and 6 months to manage residual inflammation and reinforce oral hygiene. Control Group Methodology Participants allocated to the control group receive standard oral hygiene instructions and motivation only, without active periodontal treatment during the study period. Oral hygiene education is delivered at baseline and reinforced at the 3- and 6-month follow-up visits. This includes instruction on proper tooth-brushing technique, interdental cleaning, and general advice on plaque control and oral health maintenance.No professional periodontal instrumentation (such as scaling and root planing) is performed in the control group during the active study phase. In accordance with ethical standards, participants in the control group are offered full periodontal treatment after completion of the final 6-month follow-up assessment. Randomisation Process Eligible participants are randomly allocated to either the treatment group or the control group using computer-generated randomisation with a 1:1 allocation ratio. The randomisation sequence is generated prior to study initiation using a random number function in Microsoft Excel. Each participant is assigned a unique study identification code following confirmation of eligibility and written informed consent. Allocation is concealed in a password-protected digital file and is revealed only after baseline assessments are completed. This procedure is used to minimise selection bias and ensure balanced group assignment. | |
| Intervention type | Procedure/Surgery | |
| Primary outcome measure(s) |
| |
| Key secondary outcome measure(s) |
| |
| Completion date | 28/02/2026 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 70 Years |
| Sex | All |
| Target sample size at registration | 100 |
| Total final enrolment | 89 |
| Key inclusion criteria | 1. Age 18-70 years 2. T2DM diagnosis 3. HbA1c ≥ 7% 4. More than 10 teeth present 5. Periodontitis present ≥ 4 teeth, at least one site PD ≥ 5mm 6. BOP ≥ 10% |
| Key exclusion criteria | 1. Professional periodontal treatment within the last 6 months 2. Systemic antibiotics within the last 3 months 3. Systemic diseases that may affect the response or direct periodontal damage 4. Current or previous oral mucosal diseases (e.g. Pemphigus, Lichen planus, Behcet's syndrome, etc.) 5. Pregnancy or breastfeeding 6. Inability to follow up at 0/3/6 months 7. Refusal to consent participation |
| Date of first enrolment | 12/06/2024 |
| Date of final enrolment | 31/08/2025 |
Locations
Countries of recruitment
- Albania
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | in Albanian | 19/01/2026 | No | Yes |
Additional files
Editorial Notes
19/01/2026: Trial's existence confirmed by University of Medicine Tirana.
