Periodontal infrabony defects treatment with bone grafts mixed with Emdogain vs. mixed with cross-linked hyaluronic acid
| ISRCTN | ISRCTN68819973 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN68819973 |
| Secondary identifying numbers | ME/2024 |
- Submission date
- 22/10/2024
- Registration date
- 28/10/2024
- Last edited
- 13/08/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Periodontal regeneration aims to restore the structure and function of the periodontal apparatus lost due to periodontal disease. Infrabony defects present a significant challenge in periodontal therapy. Current regenerative treatments for infrabony defects include bone substitutes mixed with biomaterials such as crosslinked hyaluronic acid (CLHA) or enamel matrix derivatives (EMD), each with unique properties and mechanisms of action. This study compares the clinical and radiological outcomes after treating infrabony defects with bone grafts mixed with CLHA or EMD.
Who can participate?
Patients aged 18-65 years old with periodontitis Stage II-IV and the presence of at least one infrabony defect of at least 4 mm in depth
What does the study involve?
This study compares two safe and approved ways of treating a specific type of bone defect in the gums. The treatments involve using bone grafts combined with either CLHA or EMD. These materials are commonly used in dental surgeries to help the gums and bones regenerate after damage caused by gum disease.
What are the possible benefits and risks of participating?
Both treatments have been tested and used successfully in many cases of gum disease. This study does not include experimental or untested procedures. Both treatments are safe and are regularly used by periodontists worldwide. The risks of participating are minor and are related to the usual risks of periodontal regenerative surgery: minor localized oedema, moderate gum recession, sometimes moderate tooth sensitivity.
Where is the study run from?
The University Clinic of Periodontology of Victor Babes University of Medicine and Pharmacy, Timisoara, Romania
When is the study starting and how long is it expected to run for?
October 2024 to December 2026
Who is funding the study?
The University Clinic of Periodontology of Victor Babes University of Medicine and Pharmacy, Timisoara, Romania
Who is the main contact?
Dr Meizi Eliezer, meizi.eliezer@gmail.com
Contact information
Public, Scientific, Principal Investigator
Golomb 71
Herzlya
463055
Israel
 ORCID ID |
0000-0003-2164-1272 |
|---|---|
| Phone | +972522577260 |
| meizi.eliezer@gmail.com |
Scientific
Str. Emanoil Gojdu 5
Timisoara
300176
Romania
| Phone | +40744521470 |
|---|---|
| s.stratul@gmail.com |
Study information
| Study design | Single-blind randomized controlled trial |
|---|---|
| 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 outcomes after treatment of infrabony defects with bone grafts mixed with cross-linked hyaluronic acid or enamel matrix derivative: a 12-month randomized controlled trial |
| Study objectives | It is hypothesized that bone grafts mixed with cross-linked hyaluronic acid (CLHA) will demonstrate equivalent regenerative outcomes compared to enamel matrix derivatives in treating infrabony defects. |
| Ethics approval(s) |
Approved 21/10/2024, The Committee on Research Ethics of the Victor Babes University of Medicine and Pharmacy Timisoara (P-ta Eftimie Murgu nr. 2, Timisoara, 300041, Romania; +40744521470; cecs@umft.ro), ref: 51/21.10.2024 |
| Health condition(s) or problem(s) studied | Surgical regenerative treatment of infrabony periodontal defects |
| Intervention | In patients who completed steps 1 and 2 of periodontal therapy but failed to achieve the endpoints of therapy (no periodontal pockets >4 mm with bleeding on probing or no deep periodontal pockets ≥6 mm), the third (surgical) step of therapy will be performed. Infrabony defects will go through periodontal regeneration therapy. Under local anesthesia, full-thickness flaps will be raised to expose the infrabony defects. After debridement, Group A defects will be treated with bone grafts mixed with cross-linked hyaluronic acid (CLHA), while Group B defects the bone grafts will be mixed with EMD. Flaps will be repositioned and sutured. Patients will undergo standard post-operative care for regenerative procedures. Sutures will be removed 2 weeks after the surgery, and gentle brushing of the operated areas will be resumed after one more week. Patients will enter supportive periodontal care, depending on the gingival and periodontal status. Block randomisation is used. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Clinical attachment level (CAL) gain measured using calibrated periodontal probe (PCP-UNC15 HuFriedy )with a consistent reference point (CEJ) at 6- and 12-months post-surgery |
| Secondary outcome measures | 1. Probing depth (PD) is measured using a calibrated manual periodontal probe with measurements taken at six sites per tooth at baseline, 6 months, and 12 months post-surgery 2. Reduction of BOP is measured using the calculated percentage of sites with BOP (BOP Percentage = Total number of sites probed / Number of sites with bleeding × 100) at baseline, 6 months, and 12 months post-surgery 3. Radiographic bone fill is measured using Linear Bone Fill Measurements at 6 months and 12 months post-surgery 4. Gingival recession is measured using direct clinical measurements with a periodontal probe from the CEJ to the free gingival margin at baseline, 6 months, and 12 months 5. Post-operative pain is measured using the Visual Analog Scale (VAS) at immediately post-op (within 2-4 hours), Day 1 (24 hours post-surgery), Day 3 (72 hours post-surgery), Day 7 (1 week post-surgery), Day 14, and 1 month for delayed pain assessment |
| Overall study start date | 21/10/2024 |
| Completion date | 31/12/2026 |
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 defects |
| Total final enrolment | 72 |
| Key inclusion criteria | 1. Patients aged 18-65 years with periodontitis Stage II-IV 2. Presence of at least one infrabony defect of at least 4mm in depth 3. No systemic conditions affecting periodontal healing 4. Non-smokers/smoking up to 8 cigarettes a day |
| Key exclusion criteria | 1. Horizontal defects 2. Pregnancy or lactation 3. Allergies to study materials 4. Smoking more than 10 cigarettes/ day |
| Date of first enrolment | 23/10/2024 |
| Date of final enrolment | 01/08/2025 |
Locations
Countries of recruitment
- Romania
Study participating centre
Timișoara
300176
Romania
Sponsor information
University/education
University Clinic of Periodontology, University Clinic of Periodontology, Bv. Revolutiei 9
Timisoara
300041
Romania
| Phone | +40744521470 |
|---|---|
| s.stratul@gmail.com | |
| Website | https://www.umft.ro/ro/acasa/ |
"ROR" |
https://ror.org/00afdp487 |
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | 01/09/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The results of the study will be published in journals with impact factor. |
| IPD sharing plan | The datasets generated during and/or analyzed during the current study will be available upon request from Dr Meizi Eliezer and from Prof. Dr Stefan-Ioan Stratul |
Editorial Notes
13/08/2025: Total final enrolment added.
18/06/2025: The recruitment end date was changed from 01/06/2025 to 01/08/2025.
23/10/204: Study's existence confirmed by the Committee on Research Ethics of the Victor Babes University of Medicine and Pharmacy Timisoara.
