Plain English Summary
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
Trial website
Contact information
Type
Scientific
Primary contact
Dr Rudwan Kazwini
ORCID ID
Contact details
Mashrou Dummar Jazereh 19 Al-Ameen building
Damascus
00000
Syria
+963 932652958
rudwan-den@hotmail.com
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
Nil known
Study information
Scientific title
A comparison between eugenol-free dressing (Coe-Pack) and absorbed dressing (Reso-Pac) after surgical removal of gingival pigmentation (spilt mouth study)
Acronym
Study hypothesis
The new cellulose-based dressing (Reso-Pac) will be more successful in healing wounds compared to the traditional dressing (Coe-Pack)
Ethics approval
Approved 18/6/2019, Damascus University Ethics Board (Mazzeh Highway, Damascus, Syria; +963 1133923486; sr.srd@damasuniv.edu.sy), ref: co2733
Study design
Split mouth randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Drug names
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 trial start date
20/04/2019
Overall trial end date
15/01/2021
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Healthy volunteer
Age group
Adult
Gender
Both
Target number of participants
10 patients (20 surgical site 2 for each patient)
Participant exclusion criteria
1. Systematic disease and hormone disorder
2. Medication that could lead to gingival pigmentation
3. Periodontitis
4. Smokers
5. Pregnant and breastfeeding
Recruitment start date
19/11/2019
Recruitment end date
20/12/2020
Locations
Countries of recruitment
Syria
Trial participating centre
Damascus University
Department of Periodontology
Mazzah Highway
Damascus
00000
Syria
Sponsor information
Organisation
Damascus University
Sponsor details
Alabaramkeh
Damascus
00000
Syria
+963 1133923192
info@damascusuniversity.edu.sy
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Damascus University
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal.
IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.
Intention to publish date
15/01/2022
Participant level data
Available on request
Basic results (scientific)
Publication list