PeriodontitisNCT02874963
FM-SRP and Tooth Extraction Improve Type 2 Diabetes Mellitus in Periodontitis
A study testing Surgical Periodontal Treatment, Non Surgical Periodontal Treatment includes scaling root planing with UDS-J Ultrasonic Scaler. and Non Surgical Periodontal Treatment includes post operative mouth wash with Listerine® (ethanol 21.6%, methyl salicylate 0.06%, menthol 0.042%, thymol 0.064% and eucalyptol 0.092%) in people with Periodontitis and Type 2 Diabetes Mellitus, run by University Clinical Centre of Kosova at 1 site in Kosovo.
Trial summary
This intervention study is designed to evaluate the effects of non-surgical procedure in addition to surgical procedure on systemic inflammation and glycemic control in with type 2 diabetes mellitus patients with periodontitis in comparison with non-diabetic periodontic patients. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Periodontitis, Type 2 Diabetes Mellitus
- What is being tested?
- Surgical Periodontal Treatment, Non Surgical Periodontal Treatment includes scaling root planing with UDS-J Ultrasonic Scaler. and Non Surgical Periodontal Treatment includes post operative mouth wash with Listerine® (ethanol 21.6%, methyl salicylate 0.06%, menthol 0.042%, thymol 0.064% and eucalyptol 0.092%)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteKosovo
- Study dates
- Nov 2015to Oct 2016
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with type 2 Diabetes Mellitus; having a baseline HbA1c ≥ 6.5%, at least 10 teeth in the functional dentition (excluding third molars) and a clinical diagnosis of periodontal disease with at least one site with probing depth (PD) ≥ 5mm, and two teeth with attachment lost ≥ 6mm and no modification in the pharmacological treatment of diabetes during the study period.
Who cannot join
- Pregnancy or lactation, major diabetic complications, uses of antibiotic therapy or non-steroidal anti-inflammatory drug therapy 4 months before the first visit.
Trial locations and contacts
1 site in 1 country.
Kosovo1 site, 1 recruiting
- Recruiting
Oral Surgery, Dental Polyclinic (HUCSK)
Peja, 10000
Sheribane Anadolli, Dr, +38139433-291, qshm_peja@hotmail.com
Dashnor Bukleta, Dr
About this study
Official title: Impact of Combined Non-surgical and Surgical Periodontal Treatment in Patients With Type 2 Diabetes Mellitus
This intervention study is designed to evaluate the effects of non-surgical procedure in addition to surgical procedure on systemic inflammation and glycemic control in with type 2 diabetes mellitus patients with periodontitis in comparison with non-diabetic periodontic patients.
Read the detailed description
In a randomize, prospective study 200 patients from the endocrinology department of "Peja's Regional Hospital" and Dental Polyclinic at city of Peja, will be assessed and examined for eligibility. Personal interviews will be used to collect the baseline data from each participant using a pre structured questionnaire.
After clinical examination, 160 patients aged 30-70 years will be selected for the study. These will be further divided in four groups: type 2 diabetes mellitus group (with or without initial periodontal therapy) and non-diabetic group (with or without initial periodontal therapy).
All the patients will be with periodontal disease and at least one tooth extraction will perform. Previous to surgery procedures, in particular in the two groups with an adjunctive non surgical periodontal treatment such as full mouth tooth cleaning will be included: full-mouth scaling and root planing (FM-SRP) with ultrasonic device (UDS-J Ultrasonic Scaler, Guilin Woodpecker Medical Instrument) and periodontal curets for mechanical debridement of the supra- and sub-gingival plaque and calculus.
Post operative rinsing will be followed with antiseptic solution Listerine® (ethanol 21.6%, methyl salicylate 0.06%, menthol 0.042%, thymol 0.064% and eucalyptol 0.092%) as a mouthwash thrice a day for 3 weeks.
- Conditions
- Periodontitis, Type 2 Diabetes Mellitus
- Being tested
- Surgical Periodontal Treatment, Non Surgical Periodontal Treatment includes scaling root planing with UDS-J Ultrasonic Scaler., Non Surgical Periodontal Treatment includes post operative mouth wash with Listerine® (ethanol 21.6%, methyl salicylate 0.06%, menthol 0.042%, thymol 0.064% and eucalyptol 0.092%)
- Keywords
- Diabetes, Oral Hygiene, Periodontal Surgery, Periodontal Medicine
- Medical subject headings
- Periodontitis, Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical Periodontal TreatmentProcedure or surgery
Also called Tooth Extraction
In the patient's with periodontal disease at least one tooth extraction will be performed.
Non Surgical Periodontal Treatment includes scaling root planing with UDS-J Ultrasonic Scaler.Device
Also called FM-SRP
Previous to surgery procedures, in particular in the two groups with an adjunctive non surgical periodontal treatment such as full mouth tooth cleaning will be included: full-mouth scaling and root planing (FM-SRP) with ultrasonic device (UDS-J Ultrasonic Scaler, Guilin Woodpecker Medical Instrument) and periodontal curets for mechanical debridement of the supra- and sub-gingival plaque and calculus.
Non Surgical Periodontal Treatment includes post operative mouth wash with Listerine® (ethanol 21.6%, methyl salicylate 0.06%, menthol 0.042%, thymol 0.064% and eucalyptol 0.092%)Drug
Also called Mouth wash
Previous to surgery procedures, in particular in the two groups with an adjunctive non surgical periodontal treatment such as full mouth tooth cleaning will be included mouth wash with Listerine® (ethanol 21.6%, methyl salicylate 0.06%, menthol 0.042%, thymol 0.064% and eucalyptol 0.092%) for the 3 weeks after tooth extraction and cleaning.
| Study group | Role | What they receive |
|---|---|---|
| Surgical periodontal treatment | Active comparator | Type 2 Diabetes Patients with periodontitis (without initial non-surgical periodontal therapy) at least one tooth extraction will be performed.
Non-Diabetes Patients with periodontitis (without initial non-surgical periodontal therapy) at least one tooth extraction will be performed.
Intervention:
Procedure: Surgery (Tooth Extraction) Receives: Procedure: Surgical Periodontal Treatment |
| Surgical and non-surgical periodontal treatment | Active comparator | Type 2 Diabetes Patients with periodontitis (with initial non-surgical periodontal therapy) at least one tooth extraction will be performed.
Non-Diabetes Patients with periodontitis (with initial non-surgical periodontal therapy) at least one tooth extraction will be performed.
Interventions:
Procedure: Surgery (Tooth Extraction)
Procedure: Non-surgical periodontal therapy-full mouth scaling and root planing (FM-SRP) with ultrasonic device and periodontal curets for mechanical debridement of the supra- and sub-gingival plaque and calculus, post operative rinsing thrice a day for 3 weeks. Receives: Procedure: Surgical Periodontal Treatment; Device: Non Surgical Periodontal Treatment includes scaling root planing with UDS-J Ultrasonic Scaler.; Drug: Non Surgical Periodontal Treatment includes post operative mouth wash with Listerine® (ethanol 21.6%, methyl salicylate 0.06%, menthol 0.042%, thymol 0.064% and eucalyptol 0.092%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemical parameter: HbA1c (mean value in %),
The changes in levels of glycated haemoglobin after periodontal treatment.
Measured: Baseline and 3 months after
Biochemical parameter: high sensitive C-Reactive Protein - hs-CRP (mean value in mg/L)
The changes in levels of c-reactive protein after periodontal treatment.
Measured: Baseline and 3 months after
Secondary outcomes (4)
Bleeding on probing (BOP) (expressed in %)
The changes in bleeding on probing after periodontal treatment.
Measured: Baseline and 3 months after
Mean attachment level (MAL) (mean in mm, as a measure of periodontal parameter)
The changes in clinical attachment level after periodontal treatment.
Measured: Baseline and 3 months after
Plaque index (PI) (expressed in %)
The changes in plaque index after periodontal treatment.
Measured: Baseline and 3 months after
Mean probing depth (PD) (mean in mm, as a measure of periodontal parameter)
The changes in probing pocket depth after periodontal treatment.
Measured: Baseline and 3 months after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2016 (estimated)
- Study startNov 2015
- Primary completionSep 2016 (estimated)
- Study completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for PeriodontitisStudies 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
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Clinical Centre of Kosova
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ljubljana, Faculty of Medicine
- Responsible party
- Principal investigator, Dashor Bukleta, University Clinical Centre of Kosova
- Investigators
- Dashnor Bukleta, Dr, Principal investigator, Department of Oral Medicine and Periodontology, Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02874963
- Sponsor's protocol ID
- HUCSK
- Status last verified
- Aug 2016
- First submitted
- 1 Aug 2016
- Last updated
- 22 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
American Diabetes Association. Executive summary: Standards of medical care in diabetes--2014. Diabetes Care. 2014 Jan;37 Suppl 1:S5-13. doi: 10.2337/dc14-S005. No abstract available.
PubMed 24357214Stratton IM, Adler AI, Neil HA, Matthews DR, Manley SE, Cull CA, Hadden D, Turner RC, Holman RR. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study. BMJ. 2000 Aug 12;321(7258):405-12. doi: 10.1136/bmj.321.7258.405.
PubMed 10938048Zeqiri S, Ylli A, Zeqiri N. The effect of physical activity in glycemia in patients with diabetes mellitus. Med Arh. 2007;61(3):146-9.
PubMed 18232276Jerliu N, Toci E, Burazeri G, Ramadani N, Brand H. Prevalence and socioeconomic correlates of chronic morbidity among elderly people in Kosovo: a population-based survey. BMC Geriatr. 2013 Mar 1;13:22. doi: 10.1186/1471-2318-13-22.
PubMed 23452830Daci A, Elshani B, Giangiacomo B. Gestational diabetes mellitus (GDM) in the Republic of Kosovo: a retrospective pilot study. Med Arch. 2013;67(2):88-90. doi: 10.5455/medarh.2013.67.88-90.
PubMed 24341050Albert DA, Ward A, Allweiss P, Graves DT, Knowler WC, Kunzel C, Leibel RL, Novak KF, Oates TW, Papapanou PN, Schmidt AM, Taylor GW, Lamster IB, Lalla E. Diabetes and oral disease: implications for health professionals. Ann N Y Acad Sci. 2012 May;1255:1-15. doi: 10.1111/j.1749-6632.2011.06460.x. Epub 2012 Mar 12.
PubMed 22409777Mealey BL, Oates TW; American Academy of Periodontology. Diabetes mellitus and periodontal diseases. J Periodontol. 2006 Aug;77(8):1289-303. doi: 10.1902/jop.2006.050459.
PubMed 16881798Loe H. Periodontal disease. The sixth complication of diabetes mellitus. Diabetes Care. 1993 Jan;16(1):329-34. No abstract available.
PubMed 8422804Tsai C, Hayes C, Taylor GW. Glycemic control of type 2 diabetes and severe periodontal disease in the US adult population. Community Dent Oral Epidemiol. 2002 Jun;30(3):182-92. doi: 10.1034/j.1600-0528.2002.300304.x.
PubMed 12000341Touger-Decker R, Schaefer M, Flinton R, Steinberg L. Effect of tooth loss and dentures On diet habits. J Prosthet Dent 1996;75:831.
Kamberi B, Hoxha V, Stavileci M, Dragusha E, Kuci A, Kqiku L. Prevalence of apical periodontitis and endodontic treatment in a Kosovar adult population. BMC Oral Health. 2011 Nov 29;11:32. doi: 10.1186/1472-6831-11-32.
PubMed 22126237Begzati A, Meqa K, Siegenthaler D, Berisha M, Mautsch W. Dental health evaluation of children in kosovo. Eur J Dent. 2011 Jan;5(1):32-9.
PubMed 21228954Saremi A, Nelson RG, Tulloch-Reid M, Hanson RL, Sievers ML, Taylor GW, Shlossman M, Bennett PH, Genco R, Knowler WC. Periodontal disease and mortality in type 2 diabetes. Diabetes Care. 2005 Jan;28(1):27-32. doi: 10.2337/diacare.28.1.27.
PubMed 15616229Pucher J, Stewart J. Periodontal disease and diabetes mellitus. Curr Diab Rep. 2004 Feb;4(1):46-50. doi: 10.1007/s11892-004-0011-y.
PubMed 14764280Norris SL, Engelgau MM, Narayan KM. Effectiveness of self-management training in type 2 diabetes: a systematic review of randomized controlled trials. Diabetes Care. 2001 Mar;24(3):561-87. doi: 10.2337/diacare.24.3.561.
PubMed 11289485
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Combined Non-surgical and Surgical Periodontal Treatment in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT02874963
- Acronym / sponsor ID
- HUCSK
- Conditions
- Periodontitis, Type 2 Diabetes Mellitus
- Keywords
- Diabetes, Oral Hygiene, Periodontal Surgery, Periodontal Medicine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University Clinical Centre of KosovaUniversity, hospital or other
- Collaborators
- University of Ljubljana, Faculty of Medicine
- Study start
- Nov 2015
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 22 Aug 2016 (estimated)
- 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.
This intervention study is designed to evaluate the effects of non-surgical procedure in addition to surgical procedure on systemic inflammation and glycemic control in with type 2 diabetes mellitus patients with periodontitis in comparison with non-diabetic periodontic patients.
Detailed description
In a randomize, prospective study 200 patients from the endocrinology department of "Peja's Regional Hospital" and Dental Polyclinic at city of Peja, will be assessed and examined for eligibility. Personal interviews will be used to collect the baseline data from each participant using a pre structured questionnaire.
After clinical examination, 160 patients aged 30-70 years will be selected for the study. These will be further divided in four groups: type 2 diabetes mellitus group (with or without initial periodontal therapy) and non-diabetic group (with or without initial periodontal therapy).
All the patients will be with periodontal disease and at least one tooth extraction will perform. Previous to surgery procedures, in particular in the two groups with an adjunctive non surgical periodontal treatment such as full mouth tooth cleaning will be included: full-mouth scaling and root planing (FM-SRP) with ultrasonic device (UDS-J Ultrasonic Scaler, Guilin Woodpecker Medical Instrument) and periodontal curets for mechanical debridement of the supra- and sub-gingival plaque and calculus.
Post operative rinsing will be followed with antiseptic solution Listerine® (ethanol 21.6%, methyl salicylate 0.06%, menthol 0.042%, thymol 0.064% and eucalyptol 0.092%) as a mouthwash thrice a day for 3 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical periodontal treatment | Active comparator | Procedure: Surgical Periodontal TreatmentType 2 Diabetes Patients with periodontitis (without initial non-surgical periodontal therapy) at least one tooth extraction will be performed. Non-Diabetes Patients with periodontitis (without initial non-surgical periodontal therapy) at least one tooth extraction will be performed. Intervention: Procedure: Surgery (Tooth Extraction) |
| Surgical and non-surgical periodontal treatment | Active comparator | Procedure: Surgical Periodontal Treatment, Device: Non Surgical Periodontal Treatment includes scaling root planing with UDS-J Ultrasonic Scaler., Drug: Non Surgical Periodontal Treatment includes post operative mouth wash with Listerine® (ethanol 21.6%, methyl salicylate 0.06%, menthol 0.042%, thymol 0.064% and eucalyptol 0.092%)Type 2 Diabetes Patients with periodontitis (with initial non-surgical periodontal therapy) at least one tooth extraction will be performed. Non-Diabetes Patients with periodontitis (with initial non-surgical periodontal therapy) at least one tooth extraction will be performed. Interventions: Procedure: Surgery (Tooth Extraction) Procedure: Non-surgical periodontal therapy-full mouth scaling and root planing (FM-SRP) with ultrasonic device and periodontal curets for mechanical debridement of the supra- and sub-gingival plaque and calculus, post operative rinsing thrice a day for 3 weeks. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosed with type 2 Diabetes Mellitus; having a baseline HbA1c ≥ 6.5%, at least 10 teeth in the functional dentition (excluding third molars) and a clinical diagnosis of periodontal disease with at least one site with probing depth (PD) ≥ 5mm, and two teeth with attachment lost ≥ 6mm and no modification in the pharmacological treatment of diabetes during the study period.
Key exclusion criteria (1 listed)
- Pregnancy or lactation, major diabetic complications, uses of antibiotic therapy or non-steroidal anti-inflammatory drug therapy 4 months before the first visit.
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 |
|---|---|---|
| Surgical Periodontal TreatmentAlso: Tooth ExtractionIn the patient's with periodontal disease at least one tooth extraction will be performed. | Procedure or surgery | Surgical and non-surgical periodontal treatment, Surgical periodontal treatment |
| Non Surgical Periodontal Treatment includes scaling root planing with UDS-J Ultrasonic Scaler.Also: FM-SRPPrevious to surgery procedures, in particular in the two groups with an adjunctive non surgical periodontal treatment such as full mouth tooth cleaning will be included: full-mouth scaling and root planing (FM-SRP) with ultrasonic device (UDS-J Ultrasonic Scaler, Guilin Woodpecker Medical Instrument) and periodontal curets for mechanical debridement of the supra- and sub-gingival plaque and calculus. | Device | Surgical and non-surgical periodontal treatment |
| Non Surgical Periodontal Treatment includes post operative mouth wash with Listerine® (ethanol 21.6%, methyl salicylate 0.06%, menthol 0.042%, thymol 0.064% and eucalyptol 0.092%)Also: Mouth washPrevious to surgery procedures, in particular in the two groups with an adjunctive non surgical periodontal treatment such as full mouth tooth cleaning will be included mouth wash with Listerine® (ethanol 21.6%, methyl salicylate 0.06%, menthol 0.042%, thymol 0.064% and eucalyptol 0.092%) for the 3 weeks after tooth extraction and cleaning. | Drug | Surgical and non-surgical periodontal treatment |
Primary outcome
Biochemical parameter: HbA1c (mean value in %),
Time frame: Baseline and 3 months after
The changes in levels of glycated haemoglobin after periodontal treatment.
Biochemical parameter: high sensitive C-Reactive Protein - hs-CRP (mean value in mg/L)
Time frame: Baseline and 3 months after
The changes in levels of c-reactive protein after periodontal treatment.
4 secondary outcomes
Bleeding on probing (BOP) (expressed in %)
Time frame: Baseline and 3 months after
Mean attachment level (MAL) (mean in mm, as a measure of periodontal parameter)
Time frame: Baseline and 3 months after
Plaque index (PI) (expressed in %)
Time frame: Baseline and 3 months after
Mean probing depth (PD) (mean in mm, as a measure of periodontal parameter)
Time frame: Baseline and 3 months after
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2016.
- Background: PubMed 24357214American Diabetes Association. Executive summary: Standards of medical care in diabetes--2014. Diabetes Care. 2014 Jan;37 Suppl 1:S5-13. doi: 10.2337/dc14-S005. No abstract available.
- Background: PubMed 10938048Stratton IM, Adler AI, Neil HA, Matthews DR, Manley SE, Cull CA, Hadden D, Turner RC, Holman RR. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study. BMJ. 2000 Aug 12;321(7258):405-12. doi: 10.1136/bmj.321.7258.405.
- Background: PubMed 18232276Zeqiri S, Ylli A, Zeqiri N. The effect of physical activity in glycemia in patients with diabetes mellitus. Med Arh. 2007;61(3):146-9.
- Background: PubMed 23452830Jerliu N, Toci E, Burazeri G, Ramadani N, Brand H. Prevalence and socioeconomic correlates of chronic morbidity among elderly people in Kosovo: a population-based survey. BMC Geriatr. 2013 Mar 1;13:22. doi: 10.1186/1471-2318-13-22.
- Background: PubMed 24341050Daci A, Elshani B, Giangiacomo B. Gestational diabetes mellitus (GDM) in the Republic of Kosovo: a retrospective pilot study. Med Arch. 2013;67(2):88-90. doi: 10.5455/medarh.2013.67.88-90.
- Background: PubMed 22409777Albert DA, Ward A, Allweiss P, Graves DT, Knowler WC, Kunzel C, Leibel RL, Novak KF, Oates TW, Papapanou PN, Schmidt AM, Taylor GW, Lamster IB, Lalla E. Diabetes and oral disease: implications for health professionals. Ann N Y Acad Sci. 2012 May;1255:1-15. doi: 10.1111/j.1749-6632.2011.06460.x. Epub 2012 Mar 12.
- Background: PubMed 16881798Mealey BL, Oates TW; American Academy of Periodontology. Diabetes mellitus and periodontal diseases. J Periodontol. 2006 Aug;77(8):1289-303. doi: 10.1902/jop.2006.050459.
- Background: PubMed 8422804Loe H. Periodontal disease. The sixth complication of diabetes mellitus. Diabetes Care. 1993 Jan;16(1):329-34. No abstract available.
- Background: PubMed 12000341Tsai C, Hayes C, Taylor GW. Glycemic control of type 2 diabetes and severe periodontal disease in the US adult population. Community Dent Oral Epidemiol. 2002 Jun;30(3):182-92. doi: 10.1034/j.1600-0528.2002.300304.x.
- BackgroundTouger-Decker R, Schaefer M, Flinton R, Steinberg L. Effect of tooth loss and dentures On diet habits. J Prosthet Dent 1996;75:831.
- Background: PubMed 22126237Kamberi B, Hoxha V, Stavileci M, Dragusha E, Kuci A, Kqiku L. Prevalence of apical periodontitis and endodontic treatment in a Kosovar adult population. BMC Oral Health. 2011 Nov 29;11:32. doi: 10.1186/1472-6831-11-32.
- Background: PubMed 21228954Begzati A, Meqa K, Siegenthaler D, Berisha M, Mautsch W. Dental health evaluation of children in kosovo. Eur J Dent. 2011 Jan;5(1):32-9.
- Individual participant dataSharing planned: Undecided
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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.
Dashnor Bukleta, Dr principal investigator
Department of Oral Medicine and Periodontology, Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical Periodontal Treatment, Non Surgical Periodontal Treatment includes scaling root planing with UDS-J Ultrasonic Scaler. and Non Surgical Periodontal Treatment includes post operative mouth wash with Listerine® (ethanol 21.6%, methyl salicylate 0.06%, menthol 0.042%, thymol 0.064% and eucalyptol 0.092%) in people with Periodontitis and Type 2 Diabetes Mellitus, run by University Clinical Centre of Kosova at 1 site in Kosovo.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 22 Aug 2016. 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 Kosovo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dashnor Bukleta, Dr (+38649210317, dashnor_bukleta@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemical parameter: HbA1c (mean value in %), (time frame: Baseline and 3 months after). 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 NCT02874963, which also lists 24 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 22 Aug 2016.