The effectiveness of aloe vera extract on socket healing after dental extraction
| ISRCTN | ISRCTN17779220 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17779220 |
| Secondary identifying numbers | 2986 |
- Submission date
- 15/04/2022
- Registration date
- 22/04/2022
- Last edited
- 22/04/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Extraction is one of the most common procedures in the dental clinic and sometimes results in complications such as dry socket, infection, and bleeding. Medicines, especially antibiotics, are often prescribed to prevent these complications, which may cause damage at the level of the individual and society in general due to the development of bacterial resistance. Even after effective healing of the extraction site, absorption must occur at the alveolar margin later, which makes dental replacement procedures more difficult in the future, and many procedures and materials have been used to reduce this absorption, and each of them has its advantages and disadvantages. The use of medicinal plants in the medical field is not new, especially the aloe vera plant, because of its well-known properties in healing wounds in addition to its anti-bacterial and anti-inflammatory effects. In addition, its effectiveness at inducing bone healing has been suggested in several studies, but no emphasis has been placed on its ability to reduce socket resorption after tooth extraction. The aim of this study is to assess the effectiveness of aloe vera extract on socket healing after dental extraction.
Who can participate?
Patients aged 18-45 years with premolars (the teeth are between the canine front teeth and the molars) that require extraction
What does the study involve?
Participants will be randomly divided into two groups. For the first group aloe vera powder will be applied after extraction with gel foam and an X-shaped suture will be made. For the second group the tooth will be extracted without applying any material and only gel foam will be placed and an X-shaped suture will be made. Pain will be evaluated 2 hours after the extraction and on the third and seventh day, healing will be evaluated on the third and seventh days, and an image will be taken immediately after the extraction and after 4 months in order to assess the dimensions of the alveolar bone.
What are the possible benefits and risks of participating?
Participants will receive oral health care instructions from the beginning of the study, and the patients can be referred to other departments if they need other oral treatments, and after the end of the study, dental implants can be performed for patients in order to replace the missing tooth in the Oral and Maxillofacial Department.
Where is the study run from?
Damascus University (Syria)
When is the study starting and how long is it expected to run for?
April 2019 to December 2022
Who is funding the study?
Damascus University (Syria)
Who is the main contact?
Nour al-Halaby
nour.ha@damascusuniversity.edu.sy
Contact information
Scientific
Mazzeh Street
PO Box 30621
Damascus
0000
Syria
| Phone | +963 (0)938518248 |
|---|---|
| nour.ha@damascusuniversity.edu.sy |
Study information
| Study design | Single-center interventional double-blind randomized controlled trial with a split-mouth design |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | 41583_PIS.pdf |
| Scientific title | Evaluation of the effectiveness of aloe vera in soft tissue healing and socket preservation after extraction |
| Study objectives | 1. Aloe vera will promote soft tissue healing after extraction 2. Aloe vera will reduce vertical and horizontal alveolar bone resorption after extraction |
| Ethics approval(s) | Approved 05/08/2019, ethics scientific committee at Damascus University (Mazzeh Street, PO Box 30621, Damascus, Syria; +963(11)339 23223; drsalloum74@hotmail.com), ref: 2986 |
| Health condition(s) or problem(s) studied | Soft tissue healing and socket preservation after dental extraction |
| Intervention | After taking the patient's medical history and evaluating their general health according to the research conditions, written consent will be taken on the content and terms of the research, and research groups will be allocated by coin-flipping. The study sample will be randomly divided into two groups: group A (aloe vera group, n = 20) and group B (control group, n = 20). All extractions will be performed by one surgeon to standardize the surgical trauma. The premolars will be extracted after making sure that they are indicated. Local anaesthesia will be lidocaine 2% with epinephrine 1/80000. In group A, aloe vera powder will be placed with gel foam with an X suture to stabilize the material inside. In group B gel foam will be placed with the X suture to standardize procedures on both sides. A sterile gauze will be placed and the patient will be asked to keep it for 1 hour to help the powder set. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 1. Pain measured using a visual analogue scale (VAS) 2 hours after extraction and on the third and seventh day 2. Healing assessed by the Landry et al. healing index on the third and seventh day 3. The dimensions of the alveolar bone assessed by cone-beam computed tomography (CBCT) immediately after extraction and after 4 months |
| Secondary outcome measures | The dimensions of the alveolar bone assessed by CBCT after 4 months |
| Overall study start date | 25/04/2019 |
| Completion date | 15/12/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 45 Years |
| Sex | Both |
| Target number of participants | 20 patients (40socket) |
| Key inclusion criteria | 1. Patients who accepted participation with written consent 2. Adults aged 18-45 years 3. Patients need bilateral upper or lower premolars extraction |
| Key exclusion criteria | 1. Heavy smokers 2. Pregnant 3. Uncontrolled diabetes patients 4. Presence of cysts or tumors at the extraction site 5. Patients with advanced periodontitis 6. Patients who are allergic to the plants of the Liliaceae family |
| Date of first enrolment | 15/10/2019 |
| Date of final enrolment | 15/10/2022 |
Locations
Countries of recruitment
- Syria
Study participating centre
Faculty of Dentistry
Mazzeh Street
PO Box 30621
Damascus
0000
Syria
Sponsor information
University/education
Mazzeh Street
PO Box 30621
Damascus
0000
Syria
| Phone | +963 (0)11 339 23223 |
|---|---|
| ap.srd@damascusuniversity.edu.sy | |
| Website | http://damasuniv.edu.sy/ |
"ROR" |
https://ror.org/03m098d13 |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- University of Damascus, جَامِعَةُ دِمَشْقَ, DU
- Location
- Syria
Results and Publications
| Intention to publish date | 25/11/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository |
| Publication and dissemination plan | Planned publication about the efficacy of aloe vera in socket healing and socket preservation after extraction. The study protocol and statistical data plan will be available upon request in Arabic. Both will be published after trial registration in a high-impact factor journal. |
| IPD sharing plan | The original data, along with the codebook and analysis scripts, will be stored in a non-publicly available repository at Damascus University. The data will consist of csv sheets with the data of the patients and R analysis scripts. The dataset will be called dataset and the dataset generated by the research, including also preprints and technical reports, will be called dataverse. The dataverse corresponding to this investigation will receive a digital object identifier (DOI). The citation has seven components. Five are human-readable: the author(s), title, year, data repository (or distributor), and version number. Two components are machine-readable: the DOI and the universal numeric fingerprint (UNF). The data generated will be de-identified using R's randomizeR package, removing all personal information. The naming convention for the archives will be date in yyyymmdd-version-identifier.extension format. The use of spaces will be avoided, being replaced by -. The original anonymized data will be published in the Mendeley data repository with restricted access once the data cleaning and exploratory analysis stage is completed. The data will be made public at the time of sending the final report to a peer-reviewed journal, with its DOI corresponding to the data associated with the research. The data will be embargoed until the final report is accepted, at which time it will become publicly available. No access restrictions will be applied to the data once the final project report has been accepted. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 22/04/2022 | No | Yes | ||
| Protocol file | 22/04/2022 | No | No |
Additional files
Editorial Notes
22/04/2022: Trial's existence confirmed by Damascus University.
