PeriodontitisANBperioNCT07027137
The Influence of Local Antibiotic Therapy on the Outcomes Following Periodontal Regeneration Procedures.
A study testing SRP+ANB+SURG and SRP+SURG in people with Periodontitis and Periodontal Diseases, run by Medical University of Bialystok at 1 site in Poland.
Trial summary
Assessmnet of the influence of local antibiotic therapy on the clinical, radiological, microbiological parameters and the inflammation mediators levels in the gingival crevicular fluid (GCF) following periodontal regeneration procedures in patients with periodontitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periodontitis, Periodontal Diseases
- What is being tested?
- SRP+ANB+SURG and SRP+SURG
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePoland
- Study dates
- 1 Aug 2019to 30 Dec 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -presence of an intrabony defect, with a pocket depth (PD) ≥ 6 mm and a radiological defect depth of ≥3 mm and width of ≥2 mm;
Who cannot join
- periodontal treatment within 3 months prior to the study;
- antibiotic therapy within 3 months prior to the study;
- smoking; presence of systemic diseases affecting periodontal healing, i.e.: immunosuppressive diseases, diabetes, osteoporosis, AIDS, hypertension treated with calcium channel blockers;
- use of steroids or other immunosuppressive drugs;
- pregnant and breastfeeding women
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Integrated Dentistry, Medical University of Białystok
Bialystok, Podlaskie Voivodeship, 15-089
About this study
Assessmnet of the influence of local antibiotic therapy on the clinical, radiological, microbiological parameters and the inflammation mediators levels in the gingival crevicular fluid (GCF) following periodontal regeneration procedures in patients with periodontitis.
Read the detailed description
Forty generally healthy adults diagnosed with stage III periodontitis were randomly divided into two groups. In the test group, SRP was performed with the subsequent application of local antibiotics (10% doxycycline) into periodontal pockets at the site of the planned surgical intervention, while in the control group SRP was performed alone. Two weeks after, on the day of the surgical treatment, the M-MIST/MIST procedure was performed in both the test and control groups with the use of enamel matrix derivative (EMD). Clinical examination was performed before and 6 and 12 months after treatment. For radiological measurements RVG was performed. For inflammation mediators levels determination in GCF samples ELISA method will be used. For microbiological assessments Real Time PCR method will be used.
- Conditions
- Periodontitis, Periodontal Diseases
- Being tested
- SRP+ANB+SURG, SRP+SURG
- Keywords
- periodontitis, periodontal regeneration, local antibiotics
- Medical subject headings
- Periodontitis, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SRP+ANB+SURGDrug
SRP (scaling and root planing) with ANB (local antibiotic application- 10%doxycycline) and SURG (regeneration procedure according to MIST/M-MIST)
SRP+SURGProcedure or surgery
SRP (scaling and root planing) and SURG (regeneration procedure according to MIST/M-MIST)
| Study group | Role | What they receive |
|---|---|---|
| SRP+SURG | Experimental | In the control group (20 subjects) SRP was performed alone. After two weeks regeneration procedure was performed. Receives: Procedure: SRP+SURG |
| SRP+ANB+SURG | Experimental | The test group consisted of 20 people participants who underwent the SRP procedure with local antibiotic application into the pocket was performed. After two weeks regeneration procedure was performed. Receives: Drug: SRP+ANB+SURG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the influence of local antibiotic therapy on the clinical, outcomes following periodontal regeneration procedures.
PD (Pocket Depth) reduction- measured from the gingival margin to the bottom of the sulcus (mm) CAL (Clinical Attachment Level) gain- measured from the cemento-enamel junction to the bottom of the sulcus (mm)
Measured: up to 12 months after treatment procedure
Secondary outcomes (1)
Assessment of the influence of local antibiotic therapy on the radiological outcomes following periodontal regeneration procedures.
RIDW- (radiological intrabony defect width)- measured from bone crest to the root surface (mm) RIDD - (radiologial intrabony defect depth) - measured from bone crest to the bottom of the defect (mm)
Measured: up to 12 months after treatment procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2025
- Study start1 Aug 2019
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- The study group consisted of 20 people participants who underwent the SRP procedure (scaling and root planing) performed with the subsequent application of local antibiotics (10% doxycycline) into periodontal pockets at the site of the planned surgical intervention, while in the control group SRP was performed alone. Two weeks after SRP, the M-MIST/MIST procedure was performed in both the test and control groups with the use of enamel matrix derivative (EMD). All surgical interventions were performed under local anesthesia (Septanest, Septodont, Paris, France). After intrabony defect exposure the granulation tissue was excised using the hand instruments (Gracey currettes (SMS), Hu-Friedy, Chicago, IL, USA), the root surface was conditioned with 24% EDTA (PrefGel®, Straumann, Switzerland) and defect was filled with enamel matrix derivative (Emdogain®, Straumann, Switzerland). Once procedure was completed, the mucoperiosteal flap was repositioned and stabilized with sutures.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Bialystok
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07027137
- Sponsor's protocol ID
- UniBial2
- Other IDs
- R-I-002/403/2019
- Acronym
- ANBperio
- Status last verified
- Jun 2025
- First submitted
- 10 Jun 2025
- Last updated
- 18 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD cannot be transferred to other people due to GDPR
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Local Antibiotic Therapy on the Outcomes Following Periodontal Regeneration Procedures.
- ClinicalTrials.gov ID
- NCT07027137
- Acronym / sponsor ID
- ANBperio / UniBial2
- Conditions
- Periodontitis, Periodontal Diseases
- Keywords
- periodontitis, periodontal regeneration, local antibiotics
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Medical University of BialystokUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 18 Jun 2025 (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.
Assessmnet of the influence of local antibiotic therapy on the clinical, radiological, microbiological parameters and the inflammation mediators levels in the gingival crevicular fluid (GCF) following periodontal regeneration procedures in patients with periodontitis.
Detailed description
Forty generally healthy adults diagnosed with stage III periodontitis were randomly divided into two groups. In the test group, SRP was performed with the subsequent application of local antibiotics (10% doxycycline) into periodontal pockets at the site of the planned surgical intervention, while in the control group SRP was performed alone. Two weeks after, on the day of the surgical treatment, the M-MIST/MIST procedure was performed in both the test and control groups with the use of enamel matrix derivative (EMD). Clinical examination was performed before and 6 and 12 months after treatment. For radiological measurements RVG was performed. For inflammation mediators levels determination in GCF samples ELISA method will be used. For microbiological assessments Real Time PCR method will be used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- The study group consisted of 20 people participants who underwent the SRP procedure (scaling and root planing) performed with the subsequent application of local antibiotics (10% doxycycline) into periodontal pockets at the site of the planned surgical intervention, while in the control group SRP was performed alone. Two weeks after SRP, the M-MIST/MIST procedure was performed in both the test and control groups with the use of enamel matrix derivative (EMD). All surgical interventions were performed under local anesthesia (Septanest, Septodont, Paris, France). After intrabony defect exposure the granulation tissue was excised using the hand instruments (Gracey currettes (SMS), Hu-Friedy, Chicago, IL, USA), the root surface was conditioned with 24% EDTA (PrefGel®, Straumann, Switzerland) and defect was filled with enamel matrix derivative (Emdogain®, Straumann, Switzerland). Once procedure was completed, the mucoperiosteal flap was repositioned and stabilized with sutures.
| Arm | Type | Receives |
|---|---|---|
| SRP+SURG | Experimental | Procedure: SRP+SURGIn the control group (20 subjects) SRP was performed alone. After two weeks regeneration procedure was performed. |
| SRP+ANB+SURG | Experimental | Drug: SRP+ANB+SURGThe test group consisted of 20 people participants who underwent the SRP procedure with local antibiotic application into the pocket was performed. After two weeks regeneration procedure was performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -presence of an intrabony defect, with a pocket depth (PD) ≥ 6 mm and a radiological defect depth of ≥3 mm and width of ≥2 mm;
Key exclusion criteria (5 listed)
- periodontal treatment within 3 months prior to the study;
- antibiotic therapy within 3 months prior to the study;
- smoking; presence of systemic diseases affecting periodontal healing, i.e.: immunosuppressive diseases, diabetes, osteoporosis, AIDS, hypertension treated with calcium channel blockers;
- use of steroids or other immunosuppressive drugs;
- pregnant and breastfeeding women
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 |
|---|---|---|
| SRP+ANB+SURGSRP (scaling and root planing) with ANB (local antibiotic application- 10%doxycycline) and SURG (regeneration procedure according to MIST/M-MIST) | Drug | SRP+ANB+SURG |
| SRP+SURGSRP (scaling and root planing) and SURG (regeneration procedure according to MIST/M-MIST) | Procedure or surgery | SRP+SURG |
Primary outcome
Assessment of the influence of local antibiotic therapy on the clinical, outcomes following periodontal regeneration procedures.
Time frame: up to 12 months after treatment procedure
PD (Pocket Depth) reduction- measured from the gingival margin to the bottom of the sulcus (mm) CAL (Clinical Attachment Level) gain- measured from the cemento-enamel junction to the bottom of the sulcus (mm)
1 secondary outcome
Assessment of the influence of local antibiotic therapy on the radiological outcomes following periodontal regeneration procedures.
Time frame: up to 12 months after treatment procedure
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 18 Jun 2025.
- Individual participant dataSharing planned: No. IPD cannot be transferred to other people due to GDPR
Related trials for Periodontitis
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
Active, not recruitingObservational study
A Retrospective Comparative Evaluation of Omega-3 and Resveratrol Supplementation in Patients With Periodontitis
Periodontitis
Recruiting
Probiotics Versus Antibiotics as an Adjuvant to Non-surgical Periodontal Treatment Among Smokers With Stage II, Grade B Periodontitis
Probiotics, Antibiotics
Recruiting
Effects of Different Activation Techniques on Antimicrobial Photodynamic Therapy in Apical Periodontitis
Apical Periodontitis, Endodontic Retreatment
Recruiting
Ozone Gel Versus Chlorohexidine Gel as an Adjunct to Non-Surgical Treatment of Stage II Periodontitis Grade B Among Smokers Patients
Ozone Gel, Chlorohexidine Gel
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 SRP+ANB+SURG and SRP+SURG in people with Periodontitis and Periodontal Diseases, run by Medical University of Bialystok at 1 site in Poland.
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 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 18 Jun 2025. 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 Poland. 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?
Assessment of the influence of local antibiotic therapy on the clinical, outcomes following periodontal regeneration procedures. (time frame: up to 12 months after treatment procedure). 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 18 Jun 2025.