Modifying the characteristics of the gums using two different approaches
| ISRCTN | ISRCTN10040718 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10040718 |
- Submission date
- 05/07/2021
- Registration date
- 15/07/2021
- Last edited
- 18/08/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Recently, more studies are addressing the importance of determining the characteristics of the gums (gingival phenotype) before dental procedures, as it has a significant impact on the outcome of restorative and regenerative therapy.
The aim of this study is to evaluate the change in gum thickness, and width of gum tissue that is keratinized, after treatment with either hyaluronic acid or injectable platelet rich fibrin.
Who can participate?
Individuals with a thin gingival phenotype can participate in this study.
What does the study involve?
Participants will be treated with hyaluronic acid (HA) on one side of the mouth and with injectable platelet rich fibrin (I-PRF) on the other. The side of the mouth on which each of the treatments will be received will be allocated at random (like tossing a coin) for all participants. The treatments will be injected into the gum on the front of the lower jaw. Injections will be given for 3 sessions with 7 days intervals.
What are the possible benefits and risks of participating?
Both HA and I-PRF promote regeneration, wound healing, and revascularization improved blood flow), and can possibly enhance the gingival phenotype by increasing thickness, and keratinized tissue width of the gums.
Where is the study run from?
Damascus University (Syria)
When is the study starting and how long is it expected to run for?
From June 2020 to January 2022
Who is funding the study?
Damascus University (Syria)
Who is the main contact?
Dr Nai Faour
Nai.faour@gmail.com
Contact information
Scientific
Damascus University
Mazzeh autostrade
Damascus
80567
Syria
 ORCID ID |
0000-0001-9664-3171 |
|---|---|
| Phone | +963 991009788 |
| nai.faour@gmail.com |
Study information
| Study design | Interventional single-center single-blinded randomized split-mouth controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Clinical comparative study of hyaluronic acid versus I-PRF to modify the gingival phenotype |
| Study objectives | 1. Injecting hyaluronic acid increases gingival thickness more than I-PRF 2. Injecting hyaluronic acid increases keratinized tissue width more than I-PRF |
| Ethics approval(s) | Approved 24/08/2020, Scientific Research and Postgraduate Studies Council of Damascus University (Damascus, Syria 80789; +963 993303359; info@damascusuniversity.edu.sy), ref: 2793 |
| Health condition(s) or problem(s) studied | Thin gingival phenotype |
| Intervention | In this split-mouth study, individuals with thin gingival phenotypes were randomly treated with hyaluronic acid and I-PRF. Allocation will be at random using a sequentially numbered opaque, sealed envelope method. HA will be injected in the gingiva on one side of the mandibular anterior region, and I-PRF will be injected on the other side for the same patient, for 3 sessions with 7 days intervals. Clinical measurements will be taken every month during the 3-month follow-up period. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | hyaluronic acid, injectable platelet rich fibrin |
| Primary outcome measure | 1. Gingival thickness measured using a no.15 endodontic spreader (inserted perpendicularly from the vestibular midpoint 1.5 mm apical of the gingival margin through the soft tissue until a hard surface is reached, with a flowable composite used to mark the reference point) and a digital caliper to assess the penetration depth between the tip and the composite at baseline, 1, and 3 months 2. Keratinized tissue width measured from gingival margin to mucogingival junction with the help of a periodontal probe (UNC 15 probe) at baseline, 1, and 3 months |
| Secondary outcome measures | 1. Plaque index measured using a probe and a mirror to evaluate the plaque accumulation on the tooth at baseline, 1, and 3 months 2. Gingival index measured using a probe and a mirror to evaluate gingival inflammation at baseline, 1, and 3 months 3. Probing depth index measured using a periodontal probe to measure the periodontal pocket depth at baseline, 1, and 3 months 4. Clinical attachment loss (CAL) measured using a periodontal probe from the CEJ Cemento-enamel junction, to the gingival margin at baseline, 1, and 3 months 5. Bleeding on probing (BOP) measured on probing at baseline, 1, and 3 months |
| Overall study start date | 01/06/2020 |
| Completion date | 10/01/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 21 patients |
| Total final enrolment | 14 |
| Key inclusion criteria | 1. Systemically healthy patients 2. Gingival thickness of the mandibular anterior teeth >1 mm 3. No pregnancy or lactation 4. Non-smokers |
| Key exclusion criteria | 1. Active orthodontic treatment 2. Previous periodontal surgery 3. Use of any drug that might affect periodontal health 4. Malocclusion, crowding, missing or supernumerary teeth 5. Tooth mobility, bruxism |
| Date of first enrolment | 01/04/2021 |
| Date of final enrolment | 01/08/2021 |
Locations
Countries of recruitment
- Syria
Study participating centre
Department of Periodontology
Mezzeh autostrade
Damascus
20872
Syria
Sponsor information
University/education
Mazzeh autostrade
Damascus
80789
Syria
| Phone | +963 993303359 |
|---|---|
| president@damasuniv.edu.sy | |
| Website | http://www.justica.sp.gov.br/sites/SJDC/ |
"ROR" |
https://ror.org/03m098d13 |
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | 01/11/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned publication of results article. |
| IPD sharing plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 18/05/2022 | 18/08/2023 | Yes | No |
Editorial Notes
18/08/2023: Publication reference added.
17/03/2022: The total final enrolment number has been changed from 21 to 14.
23/11/2021: The following changes have been made:
1. The total final enrolment number has been added.
2. The overall trial end date has been changed from 01/11/2021 to 10/01/2022 and the plain English summary has been updated to reflect this change.
15/07/2021: Internal review.
14/07/2021: Trial’s existence confirmed by Damascus University.
