Clinical, microbiological and enzymatic evaluation after "Clean&Seal® protocol in subgingival instrumentation in severe periodontitis (C&S-STEP2)
| ISRCTN | ISRCTN17852953 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17852953 |
| Secondary identifying numbers | CE-1-2024 |
- Submission date
- 23/11/2024
- Registration date
- 29/11/2024
- Last edited
- 29/11/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
This study aims to evaluate the effectiveness of adding cross-linked hyaluronic acid (xHyA, Hyadent BG®) to the “Clean&Seal®” protocol for treating advanced gum disease (stage III and IV periodontitis). The study will compare this new approach to using Perisolv® alone and a placebo.
Who can participate?
Adults with at least four deep gum pockets (≥5 mm) and significant bone loss (≥3 mm) who have at least 10 remaining teeth can participate. Participants must not have had recent periodontal or antibiotic treatment, certain severe dental conditions, or systemic diseases like uncontrolled diabetes. Pregnant or breastfeeding women, immunocompromised individuals, and those allergic to NaOCl are also excluded.
What does the study involve?
Participants will be randomly assigned to one of three groups: one receiving xHyA and Perisolv®, one receiving Perisolv® alone, and one receiving a placebo gel. All participants will undergo gum cleaning procedures under local anesthesia. Clinical, microbiological, and enzymatic parameters will be measured at the start and three months after treatment.
What are the possible benefits and risks of participating?
Participants may benefit from improved gum health and reduced inflammation. However, there are risks associated with any dental procedure, including discomfort and potential allergic reactions.
Where is the study run from?
The study is conducted at the University Clinic of Periodontology, Victor Babeș University of Medicine and Pharmacy, Timișoara (Romania)
When is the study starting and how long is it expected to run for?
November 2024 to July 2027
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Elena Catana, elena.catana@umft.ro
Contact information
Public, Scientific, Principal Investigator
Str. Martir Constantin Valceanu nr.18
Timișoara
300291
Romania
 ORCID ID |
0009-0009-2711-7691 |
|---|---|
| Phone | +40 745649445 |
| elena.catana@umft.ro |
Study information
| Study design | Interventional randomized single-blinded clinical trial with 3 months follow-up |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | University/medical school/dental school |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Clinical, microbiological and enzymatic evaluation of hyaluronic acid used in the "Clean&Seal®" protocol in step 2 of the therapy of the severe and the advanced periodontitis |
| Study acronym | C&S-STEP2 |
| Study objectives | Clean&seal protocol in subgingival instrumentation in step 2 of periodontal treatment results in better clinical, microbiological and enzymatic outcomes than Perisolv alone and placebo. |
| Ethics approval(s) |
Approved 04/11/2024, The Committee on Research Ethics of the Victor Babes University of Medicine and Pharmacy Timisoara (Pta Eftimie Murgu 2A, Timisoara, 300041, Romania; +40-256204400; cecs@umft.ro), ref: 54/04.11.2024 |
| Health condition(s) or problem(s) studied | Severe and advanced periodontitis |
| Intervention | Participants will be randomly assigned to one of three groups: test group 1 will receive treatment with hyaluronic acid and hypochlorite gel; test group 2 will use hypochlorite gel alone, and group 3 (control) will receive a placebo gel. Subgingival instrumentation will be performed under local anesthesia using ultrasonic and manual instruments, with protocol-specific gel applications preceding the instrumentation. Three months post-treatment, participants will undergo reevaluation of clinical, microbiological, histological and enzymatic parameters. Data will be analyzed using appropriate statistical methods. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Probing depth (PD) is measured using a periodontal probe (PCP-UNC 15, Hu-Friedy Manufacturing Co., Chicago, IL, USA) at baseline and 3 months post-therapy |
| Secondary outcome measures | 1. Full mouth plaque score (FMPS) is measured using a periodontal probe (PCP-UNC 15, Hu-Friedy Manufacturing Co., Chicago, IL, USA) at baseline and 3 months post-therapy 2. Full mouth bleeding score (FMBS) is measured using a periodontal probe (PCP-UNC 15, Hu-Friedy Manufacturing Co., Chicago, IL, USA) at baseline and 3 months post-therapy 3. Clinical attachment loss (CAL) is measured using a periodontal probe (PCP-UNC 15, Hu-Friedy Manufacturing Co., Chicago, IL, USA) at baseline and 3 months post-therapy 4. Gingival recession (GR) is measured using a periodontal probe (PCP-UNC 15, Hu-Friedy Manufacturing Co., Chicago, IL, USA) at baseline and 3 months post-therapy 5. Bacterial pathogens are quantitatively evaluated using PCR testing at baseline and 3 months post-therapy from sites with the highest probing pocket depth (PPD) 6. MMP-8 and IL-1 levels are analyzed using dento-ELISA immunoassay at the University Department of Biochemistry at UMVBT from gingival crevicular fluid samples collected at baseline and 3 months post-treatment from the site with the deepest probing depth 7. Inflammatory status is assessed histologically by analyzing gingival biopsies harvested using micro-tissue punches at baseline and 3 months post-treatment to determine the amount of inflammatory cells and describe the characteristics of intercellular substance in relation to the clean and seal protocol |
| Overall study start date | 04/11/2024 |
| Completion date | 30/07/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 60 |
| Key inclusion criteria | 1. Adult patients aged 18 - 65 years 2. At least 10 remaining teeth in oral cavity 3. Presence of minimum 4 sites with periodontal pockets ≥5mm, with positive BOP, radiographic bone loss ≥3mm |
| Key exclusion criteria | 1. Molars with furcation involvement class II or III 2. Endodontic lesions 3. Severe occlusal dysfunction 4. Antibiotic treatment 3 months prior to the start of the trial or during study participation 5. Systemic diseases that may influence the outcome of periodontal therapy (e.g., uncontrolled diabetes prior to or during study participation) 6. Immunocompromised patients 7. Allergic patients to NaOCl 8. Pregnant and breastfeeding women |
| Date of first enrolment | 15/11/2024 |
| Date of final enrolment | 01/01/2027 |
Locations
Countries of recruitment
- Romania
Study participating centre
Timisoara
300041
Romania
Sponsor information
University/education
Pta Eftimie Murgu nr.2A
Timișoara
300041
Romania
| Phone | +40 256204400 |
|---|---|
| doctorat@umft.ro | |
| Website | https://www.umft.ro/ |
"ROR" |
https://ror.org/00afdp487 |
Funders
Funder type
Other
No information available
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 peer-reviewed journal. |
| IPD sharing plan | The datasets generated and/or analysed during the current study will be available upon request from Dr Elena Catana, elena.catana@umft.ro |
Editorial Notes
25/11/2024: Trial's existence confirmed by The Committee on Research Ethics of the Victor Babes University of Medicine and Pharmacy Timisoara.
