Condition category
Oral Health
Date applied
24/01/2020
Date assigned
11/02/2020
Last edited
11/02/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

http://damasuniv.edu.sy/

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

Publication citations

Additional files

Editorial Notes

NHW 11/02/2020: Trial’s existence confirmed by Damascus University