Exploring the impact of antimicrobial treatments combined with dental cleaning on gum disease patients
| ISRCTN | ISRCTN14161265 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14161265 |
- Submission date
- 30/04/2025
- Registration date
- 21/05/2025
- Last edited
- 27/05/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
This study aims to find out if using an antimicrobial treatment called HybenX (HY) along with standard dental cleaning (SRP) provides extra benefits for people with severe gum disease (periodontitis). Researchers will compare the results of using both treatments together versus using only the dental cleaning.
Who can participate?
Adults over 18 years old with severe gum disease (stage III or IV periodontitis), good general health, and at least five natural teeth per quadrant can participate. Participants must have at least two sites with a pocket depth greater than 4 mm.
What does the study involve?
Participants will receive a full-mouth examination (excluding wisdom teeth) at the start and after three months. In each participant, two randomly chosen sections of the mouth will be treated with both SRP and HY, while the other two sections will receive only SRP. The study will be conducted at a single center.
What are the possible benefits and risks of participating?
Participants will benefit from free complex periodontal assessment and treatment. Risks include potential allergic reactions and chemical burns from HybenX, and complications from anesthesia such as temporary loss of sensitivity, pain at the puncture site, and local hematoma. There may also be other unpredictable risks.
Where is the study run from?
Iuliu Hațieganu University of Medicine and Pharmacy (Romania)
When is the study starting and how long is it expected to run for?
October 2024 to October 2027
Who is funding the study?
Universitatea de Medicină şi Farmacie Iuliu Haţieganu Cluj-Napoca (Romania)
Who is the main contact?
Iulia Roxana Costin (Maniac-Costin), costiniuliaroxana@yahoo.com
Contact information
Public, Scientific
Fabricii, nr. 19, bl Ro 25, sc. 5, ap. 41
Cluj-Napoca
400620
Romania
 ORCID ID |
0009-0000-3976-3935 |
|---|---|
| Phone | +40 753149589 |
| costin_iulia_roxana@elearn.umfcluj.ro |
Principal investigator
street Victor Babes, no. 15
Cluj-Napoca
400012
Romania
| ORCID ID |
0000-0002-0649-9426 |
|---|---|
| Phone | +40 722627488 |
| veve_alexandra@yahoo.com |
street Victor Babes, no. 15
Cluj-Napoca
400012
Romania
| ORCID ID |
0000-0001-8452-6410 |
|---|---|
| Phone | +40 723753324 |
| andrapopovici@gmail.com |
Study information
| Study design | Single center split-mouth randomized controlled clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital, School, University/medical school/dental school |
| Study type | Treatment |
| Participant information sheet | 47256 PIS 1 in Romanian.pdf |
| Scientific title | The use of a local desiccant antimicrobial agent in periodontal therapy: a randomized clinical trial |
| Study acronym | ULDAAPT |
| Study objectives | The study aimed to analyze whether there are differences in clinical efficacy by using a commercial desiccant antimicrobial agent Hybenx in combination with subgingival mechanical instrumentation (SRP) vs. SRP alone for the treatment of severe periodontitis cases during a three-month interval. |
| Ethics approval(s) |
Approved 03/12/2024, Ethics Committee of the County Emergency Hospital (str. Clinicilor nr. 3-5, Cluj-Naopca, 400006, Romania; +40 264597256; secretariat@scjucluj.ro), ref: 46170 |
| Health condition(s) or problem(s) studied | Periodontitis |
| Intervention | Each patient will receive an initial complete full-mouth clinical examination, excluding wisdom teeth (baseline assessment). Periodontal examinations will be performed in the clinic setting with standard equipment: dental mirror, UNC-15 periodontal probe, with millimiter markings (Hu-Friedy, Chicago, IL, USA). Based on the evaluated clinical periodontal parameters: probing depth (PD), gingival recession (GR), clinical attachment loss (CAL), and bleeding on probing scores the diagnosis of periodontitis, will be established, according to the 2018 classification system developed by the EFP and AAP. Gingival inflammation will be assessed using the Gingival Bleeding Index (GBI), and oral hygiene will be quantified with the Oral Hygiene Index (OHI) scores. The periodontal diagnosis will be set based on the presence of interdental CAL at a minimum of two non-adjacent teeth, or buccal /oral CAL ≥ 3 mm associated with PD > 3 mm. The identified periodontitis cases will be divided into four stages based on the severity of the periodontal tissue destruction: stage I (mild) periodontitis; stage II (moderate) periodontitis; stage III and stage IV (severe and very severe) periodontitis. Cases that do not meet periodontitis case definition criteria will be classified as either gingivitis or periodontally healthy cases. After initial clinical periodontal assessment and diagnosis, a standard, stepwise treatment plan will be provided for each patient based on the available recommendations, including the first-step of the periodontal therapy, comprising of patient behavioral change interventions, supragingival biofilm control, and management of modifiable risk factors. Cause-related therapy consisting of mechanical subgingival instrumentation will be initiated only after the first-step therapy endpoints will be achieved. For each periodontitis patient, two hemiarches of the four hemiarches will be treated with subgingival mechanical instrumentation (SRP) plus HybenX and will be included in the test group (SRP plus HY group), while the other two hemiarches that will receive SRP alone will be included in the control group (SRP group). After completing the study, patients will receive the other therapy steps as planned. The hemiarches (hemiarches 1 and 4) will be randomly assigned to one of the therapies (SRP plus HY or SRP alone) based on a randomization table. On the first treatment day, hemiarches 1 and 4 will be treated following random allocation (test therapy or control therapy); the following day, the other treatment will be applied for the other two hemiarches (hemiarches 2 and 3). The records of the participants will not contain any mention of treatment allocation. The list containing allocation numbers and patient’s names will be kept by the senior periodontologist, who is also responsable for patient’s recruitment. The baseline examination and the treatment will be provided by two investigators, and re-evaluations will be performed by other investigators. Investigators conducting the follow-up examination and the statistician will not be aware of the treatment type received by patients. HybenX application protocol according to the manufacturer: • Dry the tooth • Apply HybenX® via cannula before scaling and root planing in pockets deeper than 5 mm. • Wait 10–30 seconds • Remove HybenX® with supragingival and subgingival to the base of periodontal pockets suction and rinse with water until clear |
| Intervention type | Device |
| Pharmaceutical study type(s) | Pharmacodynamic |
| Phase | Phase III/IV |
| Drug / device / biological / vaccine name(s) | Hybenx (a concentrated mixture of acidified phenolics, a desiccating agent, consisting of 60% sulfonated phenolics, 28% sulfuric acid, and 12% water) |
| Primary outcome measure | Measured at baseline and follow up: 1. Probing depth (PD) is measured using a periodontal probe at six sites per tooth 2. Gingival recession (GR) is measured using a periodontal probe at six sites per tooth 3. Clinical attachment loss (CAL) is measured using a periodontal probe at six sites per tooth 4. Gingival Bleeding Index (GBI) is measured using the presence of bleeding upon probing at four sites per tooth and calculated as a percentage of bleeding sites over total sites 5. Oral Hygiene Index (IHI) is measured using the presence of visible dental plaque at four sites per tooth and calculated as a percentage of plaque-positive sites over total sites 6. Change in total probing depth (PD) is measured using a periodontal probe at six sites per tooth and compared between intervention groups |
| Secondary outcome measures | Measured at baseline and follow up: 1. Total probing depth (PD) is measured using a periodontal probe at six sites per tooth, calculating the average of all sites evaluated 2. Interproximal probing depth (PD) is measured using a periodontal probe at six sites per tooth, calculating the average of interproximal sites evaluated 3. Total clinical attachment loss (CAL) is measured using a periodontal probe at six sites per tooth, calculating the average of all sites evaluated 4. Interproximal clinical attachment loss (CAL) is measured using a periodontal probe at six sites per tooth, calculating the average of interproximal sites evaluated 5. Count of total probing depths equal to 5 mm is measured using a periodontal probe at six sites per tooth, summing the number of sites with PD = 5 mm 6. Count of interproximal probing depths equal to 5 mm is measured using a periodontal probe at six sites per tooth, summing the number of interproximal sites with PD = 5 mm 7. Count of total probing depths greater than or equal to 6 mm is measured using a periodontal probe at six sites per tooth, summing the number of sites with PD ≥ 6 mm 8. Count of interproximal probing depths greater than or equal to 6 mm is measured using a periodontal probe at six sites per tooth, summing the number of interproximal sites with PD ≥ 6 mm 9. Oral Hygiene Index (IHI) score is measured using a dental plaque detector at four sites per tooth, calculated as the percentage of plaque-positive sites over total sites 10. Gingival Bleeding Index (GBI) score is measured using a periodontal probe at four sites per tooth, calculated as the percentage of bleeding sites over total sites |
| Overall study start date | 01/10/2024 |
| Completion date | 01/10/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | All |
| Target number of participants | 60 |
| Key inclusion criteria | 1. Periodontitis stage III-IV 2. Good systemic health 3. Age>18 years 4. Minimum 5 natural teeth per quadrant 5. A minimum of 2 sites on different teeth with a pocket probing depth (PD)>4 mm |
| Key exclusion criteria | 1. Periodontal and/or antibiotic therapy within the last 6 months 2. Use of antiseptic mouthwashes in the last 3 months 3. Pregnancy 4. Severe systemic conditions 5. Immunosuppressive therapy/current radiotherapy |
| Date of first enrolment | 12/12/2024 |
| Date of final enrolment | 01/10/2026 |
Locations
Countries of recruitment
- Romania
Study participating centre
Cluj-Napoca
400012
Romania
Sponsor information
University/education
Emil Isac nr. 13
Cluj-Napoca
400023
Romania
| Phone | +40 264406839 |
|---|---|
| sd@umfcluj.ro | |
| Website | https://umfcluj.ro |
"ROR" |
https://ror.org/051h0cw83 |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- University of Medicine and Pharmacy Cluj-Napoca, Iuliu Haţieganu University of Medicine and Pharmacy, University of Medicine and Pharmacy "Iuliu Haţieganu" Cluj-Napoca, “Iuliu Hatieganu” University of Medicine and Pharmacy Cluj-Napoca, Universitatea de Medicină și Farmacie “Iuliu Hațieganu”, UMF Iuliu Hațieganu Cluj-Napoca, UMF Cluj, UMF Cluj-Napoca, UMFCLUJ, UMF
- Location
- Romania
Results and Publications
| Intention to publish date | 01/10/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from: Costin Iulia Roxana (Maniac-Costin), email address: costiniuliaroxana@yahoo.com |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | in Romanian | 21/05/2025 | No | Yes | |
| Participant information sheet | in Romanian | 21/05/2025 | No | Yes |
Additional files
- 47256 PIS 1 in Romanian.pdf
- in Romanian
- 47256 PIS 2 in Romanian.pdf
- in Romanian
Editorial Notes
27/05/2025: Contact details updated.
21/05/2025: Trial's existence confirmed by Ethics Committee of the County Emergency Hospital.
