Removing an abnormal maxillary labial frenum (a small band of tissue that connects the upper lip to the gums) using a scalpel and laser
| ISRCTN | ISRCTN10827581 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10827581 |
| Secondary identifying numbers | 21/S.M |
- Submission date
- 09/11/2023
- Registration date
- 13/11/2023
- Last edited
- 13/11/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
The frenum is a fold in the mucous membrane that connects the lip and the cheek to the tissues around the upper teeth. When these folds, called frena, are too closely attached to the gum line, it can potentially impact gum health. This can happen due to issues like difficulty in cleaning plaque or tension from muscle pull.
The aim of this study is to evaluate the pain and reinsertion of the frenum following conditional and laser assisted treatment in patients with abnormal upper labial frenum.
Who can participate?
Patients aged 15 years and over with abnormal upper labial frenum
What does the study involve?
Frenectomy with classical surgery and laser surgery and follow up for 3 months
What are the possible benefits and risks of participating?
Decrease the pain and promote the healing of the wounds and make the patients more comfort
The methods are safe and there are no expected risks.
Where is the study run from?
Damascus University (Syria)
When is the study starting and how long is it expected to run for?
January 2021 to November 2023
Who is funding the study?
Damascus University (Syria)
Who is the main contact?
Dr Aisha Sayed Taha
Aysha.sayed.taha@gmail.com
Contact information
Public, Scientific, Principal Investigator
Mazzeh
Damascus
-
Syria
 ORCID ID |
0009-0009-8580-2320 |
|---|---|
| Phone | +963 (0)994778168 |
| aisha94.taha@damascusuniversity.edu.sy |
Study information
| Study design | Interventional 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 | No participant information sheet available |
| Scientific title | A comparative clinical study between conventional surgical technique and different types of laser for frenectomy procedure |
| Study objectives | There is no difference between laser assisted technique and conventional technique for Frenectomy |
| Ethics approval(s) |
Approved 04/01/2021, Scientific Research and Postgraduate Studies Council (Baramkeh, Damascus, -, Syria; +963 (0)1133923192; ap.srd@damascusuniversity.edu.sy), ref: None provided |
| Health condition(s) or problem(s) studied | Frenectomy in patients with abnormal labial frenum |
| Intervention | In this study, individuals with abnormal maxillary labial frenum were randomly treated with a conventional technique and different types of laser. Clinical measurements will be taken every month during the 3-month follow-up period. 1st group: conventional surgical technique 2nd group: conventional surgical technique followed by application diode laser 808nm for photobiomodulation 3rd group: laser Er:YAG for surgery 4th group: laser Diode 810nm for surgery Follow up after one week, one month, 3months Randomization by website: www.random.org |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Pain is measured using a numerical scale (NS) at baseline, 24, 48, and 72 h. |
| Secondary outcome measures | 1. Reepithelialization assessment by H2O2 after one week, two weeks, three weeks, 1 month, 3 months. 2. Reinsertion of the frenum by UNC15 probe after 1 month, 3 months. |
| Overall study start date | 05/01/2021 |
| Completion date | 05/11/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 15 Years |
| Upper age limit | 55 Years |
| Sex | Both |
| Target number of participants | 4 groups, 10 patient in each group |
| Total final enrolment | 40 |
| Key inclusion criteria | 1. Systemically healthy 2. Non smoker 3. Between 15 and 55 years old 4. Not received any periodontal treatment within the last 3 months 5. Presence of at least central incisors, lateral incisors, and canines at the maxilla 6. Consent to participate in the study |
| Key exclusion criteria | 1. Any systematic disease that might interfere with wound healing process (i.e., diabetes mellitus and HIV infection) 2. Smoking 3. Antibiotics, anti-inflammatory drugs, or any other medication taken within the last 6 months that might affect the outcome of the study 4. Any hypersensitivity reactions against to paracetamol 5. Any physical limitations or restrictions that might preclude normal oral hygiene procedures |
| Date of first enrolment | 01/10/2021 |
| Date of final enrolment | 05/08/2023 |
Locations
Countries of recruitment
- Syria
Study participating centres
Faculty of Dentistry
Mezzah
Damascus
-
Syria
Faculty of mechanical and electrical engineering
Airport road
Damascus
-
Syria
Sponsor information
University/education
Albaramkeh
Damascus
-
Syria
| Phone | +963 (0)1133923192 |
|---|---|
| info@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 | 30/12/2023 |
|---|---|
| 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/will be available upon request from Prof. Dr Wael Almahdi (w.almahdi76@gmail.com). All of data of the patients will be available on request. Consent from participants was obtained. |
Editorial Notes
13/11/2023: Trial's existence confirmed by Damascus University.
