Evaluation of two protocols for non-surgical treatment of periodontitis
| ISRCTN | ISRCTN67851517 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN67851517 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | SUB/1/NN/22/001/1164 |
| Sponsor | Medical University of Białystok |
| Funder | Uniwersytet Medyczny w Białymstoku |
- Submission date
- 30/10/2025
- Registration date
- 26/11/2025
- Last edited
- 26/11/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Periodontitis is a chronic inflammatory disease of the gums that leads to bone, soft tissue and tooth loss. Scaling and root planing (SRP) is the basic treatment for periodontitis. Due to the limitations of SRP and the multiple causes of periodontal disease, new methods are being sought to support this treatment. One of them is the local use of local antibiotics such as a tazobactam/piperacillin formulation (Gelcide, MTD, Switzerland). Therefore, the aim of this study was to evaluate periodontal (gum) parameters and take samples of the gingival crevicular fluid around the gums after SRP with and without the application of a local antibiotic to the gum pockets.
Who can participate?
Patients aged over 18 years with periodontitis stage II/III
What does the study involve?
Patients were randomly assigned to two groups:
1. The study group (SRP + local antibiotic application to pockets minimum 5 mm)
2. The control group (SRP)
The study involves clinical examination of the gums and GCF sampling from deep gum pockets.
What are the possible benefits and risks of participating?
The advantage of participating in the study is the possibility of cleaning the gum pockets using mechanical methods or mechanical methods with additional local antibiotic therapy. The risk of participating is similar to that of a routine dental visit.
Where is the study run from?
Medical University of Bialystok (Poland)
When is the study starting and how long is it expected to run for?
June 2020 to June 2022
Who is funding the study?
Medical University of Bialystok (Poland)
Who is the main contact?
Dr Ewa Dolińska, ewa.dolinska@umb.edu.pl
Contact information
Public, Scientific, Principal investigator
ul. Waszyngtona 13
Białystok
15-269
Poland
 ORCID ID |
0000-0003-3122-4990 |
|---|---|
| Phone | +48 (0)85 7485905 |
| ewa.dolinska@umb.edu.pl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomized controlled clinical trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Evaluation of two protocols for non-surgical treatment of periodontitis - with or without subgingival antibiotic application |
| Study objectives | The aim of the study is to compare the clinical effects of a local antibiotic formulation (piperacillin/tazobactam) applied subgingivally to pockets with PD >5 mm after scaling and root planing (SRP) with SRP alone in patients with periodontitis. In addition, gingival crevicular fluid (GCF) will be collected during the study for molecular and microbiological testing. |
| Ethics approval(s) |
Approved 23/09/2020, Bioethics Committee Medical University of Bialystok (ul. Jana Kilińskiego 1, Bialystok, 15-089, Poland; +48 (0)85 748 54 07; komisjabioetyczna@umb.edu.pl), ref: APK.002.271.2020 |
| Health condition(s) or problem(s) studied | Periodontitis |
| Intervention | Randomisation was performed by tossing a coin before the intervention. Patients were randomly assigned to two groups: 1. The study group (SRP + local antibiotic application to pockets minimum 5 mm) 2. The control group (SRP) Study group patients were treated by scaling and root planing (SRP) and subsequently, the locally delivered preparation containing tazobactam and piperacillin was applied using a blunt cannula to four selected pockets with PD ≥5 mm. |
| Intervention type | Mixed |
| Primary outcome measure(s) |
1. Pocket depth (PD) measured in mm with periodontal probe PCUNC15 at baseline, 3 and 6 months |
| Key secondary outcome measure(s) |
Gingival crevicular fluid (GCF) sampled at baseline, 2 weeks, 3 months and 6 months and frozen for future laboratory analysis |
| Completion date | 22/06/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | All |
| Target sample size at registration | 40 |
| Total final enrolment | 38 |
| Key inclusion criteria | 1. Diagnosed periodontitis stage II or III, grade B or C 2. Presence of at least 16 teeth (at least 4 in each quadrant) 3. Presence of at least 4 deep periodontal pockets (PD ≥5 mm) 4. No professional hygiene procedures in the last 6 months 5. No systemic antibiotic therapy in the last 3 months 6. Aged over 18 years 7. Being non-smoker |
| Key exclusion criteria | 1. General contraindications to any periodontal therapy 2. Immunosuppression 3. Immunological incompetence 4. Uncontrolled diabetes 5. Pregnancy and breastfeeding 6. Alcohol and/or drug dependence 7. Patient allergic to any antibiotics 8. Patient requiring antibiotic cover prior to periodontal therapy 9. Patient with no opportunity to participate in the programme for 6 months |
| Date of first enrolment | 04/01/2021 |
| Date of final enrolment | 19/01/2022 |
Locations
Countries of recruitment
- Poland
Study participating centre
ul. Waszyngtona 13
Bialystok
15-269
Poland
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The data are available on reasonable request from Dr Ewa Dolińska (ewa.dolinska@umb.edu.pl) |
Editorial Notes
30/10/2025: Study's existence confirmed by the Medical University of Bialystok.
