Application and histologic evaluation of hyaluronic acid in the treatment of gingival papilla loss
| ISRCTN | ISRCTN12070271 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12070271 |
| Secondary identifying numbers | 01/26.01.2024 |
- Submission date
- 23/04/2024
- Registration date
- 25/04/2024
- Last edited
- 06/05/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Hyaluronic acid (HA) may affect periodontal (gum) regeneration because it is an essential component of the periodontal ligament (tissue attaching the tooth to the bone) and has been shown to play various important roles. HA has anti-inflammatory activity promoting soft and hard tissue healing. HA has already been tested in patients with chronic periodontitis (gum disease) in several clinical studies showing its beneficial effects.
Unfortunately, so far, there is no human histological (tissue) evidence of healing after the use of HA in papilla augmentation procedures (restoring lost gum tissue between teeth). Therefore, this human histological study aims to evaluate the early healing after HA gel injection.
Who can participate?
Patients aged over 18 years with periodontitis stage III, grades A and B
What does the study involve?
Participants will receive papilla augmentation procedures with hyaluronic acid gel and surgical periodontal treatment.
What are the possible benefits and risks of participating?
Participants will benefit from the periodontal surgical treatment. Hyaluronic acid products have no reported risks
Where is the study run from?
Victor Babeș University of Medicine and Pharmacy Timișoara (Romania)
When is the study starting and how long is it expected to run for?
January 2024 to April 2024
Who is funding the study?
Victor Babeș University of Medicine and Pharmacy Timișoara (Romania)
Who is the main contact?
Dr Vela Octavia Carolina, vela.octavia@umft.ro
Contact information
Public, Scientific, Principal Investigator
Str Ion Rusu Sirianu, Nr.12, Sc. C, AP. 12
Timisoara
300041
Romania
 ORCID ID |
0000-0002-8540-8149 |
|---|---|
| Phone | +40 (0)741706965 |
| vela.octavia@umft.ro |
Study information
| Study design | Single-center experimental histological study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Histological study |
| Study setting(s) | University/medical school/dental school |
| Study type | Other |
| Participant information sheet | 45357_PIS.pdf |
| Scientific title | Histologic evaluation of early papilla healing after augmentation with injectable hyaluronic acid. A proof of concept |
| Study acronym | PAPILLA-HA |
| Study objectives | The purpose of this human histological study is to histologically evaluate the healing of papillae after one injection with hyaluronic acid (HA) gel for augmentation, at three healing time points. |
| Ethics approval(s) |
Approved 26/01/2024, Scientific Research Ethics Committee of the University of Medicine and Pharmacy “Victor Babes” Timisoara (P-ta Eftimie Murgu, nr 2, Timisoara, 300041, Romania; +40 (0)256293389; comisiaeticaumft@umft.ro), ref: 08/26.01.2024 |
| Health condition(s) or problem(s) studied | Treatment of gingival papilla loss for patients diagnosed with periodontal disease |
| Intervention | After steps 1 and 2 of periodontal treatment the selected patients will receive the papilla augmentation procedure. The suitable papillae will be injected once with approximately 0.2 ml of hyaluronic acid gel (hyaDENT BG®) after local anesthesia of the area. Depending on the case, at least one papilla from every patient will be injected per week for 3 weeks. At the fourth week mark, the papillae will be harvested as part of step 3 of the periodontal surgical treatment. After harvesting papillae will be fixed in 10 % formalin solution and sent for histological analysis. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | The presence of new collagen formation and the presence of the hyaluronic acid compound detected using histological analysis after hematoxylin-eosin staining, at 1 week, 2 weeks, and 3 weeks post hyaluronic acid injection recorded dichotomously on the specimens as the presence or absence of the parameter with the following scores: 0/- (absence), 1/+ (presence low), 2/++ (presence medium), 3/+++ (presence high) |
| Secondary outcome measures | The presence and characteristics of inflammatory infiltrate, detection of granulomatous reactions, presence of interstitial edema, detected at 1 week, 2 weeks and 3 weeks after hyaluronic injection recorded dichotomously on the specimens as the presence or absence of the parameter with the following scores: 0/- (absence), 1/+ (presence low), 2/++ (presence medium), 3/+++ (presence high) |
| Overall study start date | 27/01/2024 |
| Completion date | 01/04/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 60 Years |
| Sex | Both |
| Target number of participants | 10 |
| Total final enrolment | 10 |
| Key inclusion criteria | 1. Nonsmoking, aged above 18 years 2. Presence of an uninterrupted frontal arch (maxillary or mandibular) of teeth affected by severe periodontitis 3. Presence of interproximal pockets deeper than 6 mm in at least 6 adjacent teeth 4. Class I, II, or III papillary recession, according to Nordland and Tarnow's classification (1998) 5. The distance from the contact point to the alveolar bone crest ≥5 mm 6. Keratinized tissue width of the entire area to be operated of at least 3 mm 7. Good oral hygiene - Plaque Index (PlI<1) |
| Key exclusion criteria | 1. Systemic diseases such as diabetes mellitus, hypertension, or conditions that alter the outcome of periodontal therapy 2. Pregnant or lactating women 3. Tobacco users 4. Patients with known allergies to hyaluronic acid or any excipients of the product used 5. Patients with current or previous drug intake that may predispose to gingival enlargement 6. Patients under orthodontic treatment or having orthodontic treatment in the past 6 months 7. Patients with a history of traumatic oral hygiene measures or periodontal surgeries over the last 6 months in the area of interest |
| Date of first enrolment | 27/01/2024 |
| Date of final enrolment | 01/03/2024 |
Locations
Countries of recruitment
- Romania
Study participating centre
Timișoara
300041
Romania
Sponsor information
University/education
Piata Eftimie Murgu nr 2
Timisoara
300041
Romania
| Phone | +40 (0)741706965 |
|---|---|
| doctorat@umft.ro | |
| 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 | 01/05/2024 |
|---|---|
| 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 are available from the corresponding author on reasonable request (Dr Vela Octavia Carolina, vela.octavia@umft.ro). Type of data: periodontal charts, histological analysis. Data will become available after the publication of the study and will be available for 5 years. Data will be shared for similar studies, on request from the first author. Written consent from participants will be obtained. Data from participants are anonymized. The key to the names of the participants is located in the repository. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other files | 25/04/2024 | No | No | ||
| Participant information sheet | 25/04/2024 | No | Yes | ||
| Results article | 13/07/2024 | 06/05/2025 | Yes | No |
Additional files
Editorial Notes
06/05/2025: Publication reference added.
24/04/2024: Study's existence confirmed by the Scientific Research Ethics Committee of the University of Medicine and Pharmacy “Victor Babes” Timisoara.
