A comparison between a typical dressing and an absorbed dressing after surgical removal of gum pigmentation
| ISRCTN | ISRCTN76318940 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN76318940 |
- Submission date
- 24/01/2020
- Registration date
- 11/02/2020
- Last edited
- 11/09/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Gum pigmentation (gingival pigmentation) is caused by melanin and melanin is a natural substance in the body that is found in freckles, sun spots, age spots. Some people have an overproduction of melanin in their gums. Discoloration may also be caused by long term use of certain medications.
Proper healing is a must for a successful periodontal surgery. Many new dressings are made and tested to reach a perfect dressing to insure complete and fast wound healing. The absorbed (cellulose-based) dressing (Reso-Pac) is the newest dressing. In this study, it is compared with the traditional dressing (Coe-Pack) in healing wounds.
Who can participate?
Healthy patients aged 18 – 40 years who have gingival pigmentation.
What does the study involve?
After surgical removal of gingival pigmentation, participants will receive two different types of wound dressing, one on each side of the mouth. Healing will be assessed for three weeks after the surgery.
What are the possible benefits and risks of participating?
The benefit is the potential for faster healing. The risks will be to have an allergic reaction towards the new dressing
Where is the study run from?
Damascus University Department of Periodontology (Syria)
When is the study starting and how long is it expected to run for?
November 2019 to January 2021.
Who is funding the study?
Damascus University (Syria)
Who is the main contact?
Dr Rudwan Kazwini
rudwan-den@hotmail.com
Contact information
Scientific
Mashrou Dummar Jazereh 19 Al-Ameen building
Damascus
00000
Syria
| Phone | +963 932652958 |
|---|---|
| rudwan-den@hotmail.com |
Study information
| Study design | Split mouth randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A comparison between eugenol-free dressing (Coe-Pack) and absorbed dressing (Reso-Pac) after surgical removal of gingival pigmentation (spilt mouth study) |
| Study objectives | The new cellulose-based dressing (Reso-Pac) will be more successful in healing wounds compared to the traditional dressing (Coe-Pack) |
| Ethics approval(s) | Approved 18/6/2019, Damascus University Ethics Board (Mazzeh Highway, Damascus, Syria; +963 1133923486; sr.srd@damasuniv.edu.sy), ref: co2733 |
| Health condition(s) or problem(s) studied | Gingival melanosis |
| Intervention | Surgical removal of gingival pigmentation on the maxillary using surgical scallop and putting the absorbed dressing Cellulose based (reso-pac) randomly on one side and the typical eugenol-free dressing (Coe-pak) on the other side. Randomisation: a coin is used to determine which side to put the absorbed dressing (Reso-pac) and the eugenol-free dressing (Coe-pack) Patients were followed up for three weeks after surgery. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 1. Pain: each day for 1 week post-surgery using VAS (scale 0-100) 2. Induced pain: 1 week after surgery using air abrasion of 5 seconds on every side using VAS (scale 0-100) 3. Epithelial re-formation: using blue toluidine in 1 week, 2 weeks, 3 weeks after surgery 4. Healing: using Lundry Healing index Criteria (1988) 1 week, 2 weeks, 3 weeks after surgery |
| Secondary outcome measures | Time (s) of dressing application measured using a stopwatch |
| Overall study start date | 20/04/2019 |
| Completion date | 15/01/2021 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 10 patients (20 surgical site 2 for each patient) |
| Key inclusion criteria | 1. Healthy patient with gingival pigmentation grade 3 and 4 on the maxillary 2. Aged between 18 - 40 years 3. Good oral hygiene |
| Key exclusion criteria | 1. Systematic disease and hormone disorder 2. Medication that could lead to gingival pigmentation 3. Periodontitis 4. Smokers 5. Pregnant and breastfeeding |
| Date of first enrolment | 19/11/2019 |
| Date of final enrolment | 20/12/2020 |
Locations
Countries of recruitment
- Syria
Study participating centre
Mazzah Highway
Damascus
00000
Syria
Sponsor information
University/education
Alabaramkeh
Damascus
00000
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 | 15/01/2022 |
|---|---|
| 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. |
Editorial Notes
11/09/2020: Recruitment has resumed.
20/04/2020: Due to current public health guidance, recruitment for this study has been paused.
11/02/2020: Trial’s existence confirmed by Damascus University
