Comparing collagen to collagen and hyaluronic acid in healing after impacted lower third molars surgical extraction
| ISRCTN | ISRCTN16820104 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16820104 |
| Secondary identifying numbers | MS711 |
- Submission date
- 11/06/2021
- Registration date
- 06/07/2021
- Last edited
- 06/07/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English Summary
Background and study aims
This study aims to compare using collagen and hyaluronic acid on healing after impacted lower third molars surgical extraction.
Who can participate?
Healthy adults aged 18 - 35 years who underwent bilateral impacted lower third molars surgical extraction
What does the study involve?
Two impacted lower third molars will be extracted surgically for each patient. One will be filled with collagen, the other with collagen and hyaluronic acid. The visual analogue scales (VAS) scores, facial swelling, mouth opening, soft tissue healing and radial density of the bone will be assessed.
What are the possible benefits and risks of participating?
It is crucial for maxillofacial surgeons to decrease the post-extraction complications and improve the third molar extraction socket healing by using a simple method. Both materials are safe and should not cause any additional risks. All participants will receive the same treatment.
When is the study starting and how long is it expected to run for?
February 2022 to March 2022
Where is the study run from?
Damascus University (Syria)
Who is funding the study?
Damascus University (Syria)
Who is the main contact?
Dr Moemeneh Bassam Kokash, moemena93@gmail.com
Contact information
Scientific
Mazzeh
Damascus
0096311
Syria
 ORCID ID |
0000-0002-2145-4218 |
|---|---|
| Phone | +963 945225923 |
| moemeneh3.kokash@damascusuniversity.edu.sy |
Study information
| Study design | Split-mouth interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | ISRCTN16820104_PIS.pdf |
| Scientific title | Effect of collagen and hyaluronic acid on healing after impacted lower third molars surgical extraction. (A clinical and radiographic study) |
| Study hypothesis | We are trying to test the efficacy of collagen and hyaluronic acid on healing after impacted lower third molars surgical extraction. |
| Ethics approval(s) | Approved 24/02/2020, Damascus University Rector (Baramkeh, Damascus, Syria; +966 55 506 3806; no email provided), ref: MS711 |
| Condition | Surgical extraction of symmetrical Impacted lower third molars |
| Intervention | This study is a split mouth randomized clinical trial. The patient chose a piece of coin to decide which side was to be applied collagen and which was to be applied collagen and hyaluronic acid in socket after impacted lower third molars surgical extraction. Triangle full thickness flap was reflected and necessary bone removal was performed by slow-speed straight surgical headpiece with continuous irrigation of saline solution. After the impacted molar was removed and the socket was well rinsed with saline. A randomized clinical trial was conducted, with one extraction socket being filled with collagen and the other extraction socket being filed with collagen and hyaluronic acid in the same patient. Patients returned after 1 week to have the sutures removed. They were followed up at 3 days, 7 days, 1 month, 3 months, and 6 months. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | At 3 days, 7 days, 1 month, 3 months, and 6 months: 1. Pain intensity measured using visual analogue scales (VAS) 2. Facial swelling (clinical evaluation) 3. Mouth opening (clinical evaluation) 4. Soft tissue healing (clinical evaluation) |
| Secondary outcome measures | Radial density measured using periapical digital radiographs at 1 month, 3 months and 6 months |
| Overall study start date | 04/02/2020 |
| Overall study end date | 01/03/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 35 Years |
| Sex | Both |
| Target number of participants | 20 |
| Participant inclusion criteria | 1. The patient's age (18-35) years. 2. Surgical extraction of symmetrically impacted lower third molars is indicated. 3. Good general health and there are no uncontrolled systemic diseases. 4. The integrity of the periodontal tissues and the absence of periodontal diseases. 5. Good oral health. 6. There is no allergy or contraindication to the required postoperative prescription or to the applied medicinal substances. |
| Participant exclusion criteria | 1. Pregnant 2. Diabetes mellitus 3. Hypertension 4. Compromised immune system or other systemic diseases 5. Patients with pericoronitis, infection, pathological condition in the region of surgery |
| Recruitment start date | 01/10/2020 |
| Recruitment end date | 01/09/2021 |
Locations
Countries of recruitment
- Syria
Study participating centre
Mazzah High Way
Damascus
0096311
Syria
Sponsor information
University/education
Damascus University Rector
Baramkeh
Damascus
0096311
Syria
| Phone | +963 1133923192 |
|---|---|
| info@damascusuniversity.edu.sy | |
| Website | http://damasuniv.edu.sy/ |
"ROR" |
https://ror.org/03m098d13 |
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | 01/03/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | After finishing the follow up procedure and writing the article, I am planning to publish it (with all results, statistical analysis and some photos) in Damascus University's journal, and many other international journals. |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 06/07/2021 | No | Yes | ||
| Protocol file | 06/07/2021 | No | No |
Additional files
- ISRCTN16820104_PIS.pdf
- uploaded 06/07/2021
- ISRCTN16820104_PROTOCOL.pdf
- uploaded 06/07/2021
Editorial Notes
06/07/2021: The following changes were made to the trial record:
1. Uploaded protocol (not peer-reviewed) as an additional file. Version n/a, no date.
2. The participant information sheet was uploaded as an additional file.
06/07/2021: Trial's existence confirmed by Damascus University
