HyperpigmentationNCT06031116
Efficacy of Ceramic Soft Tissue Trimming Bur Versus Conventional Scalpel Technique in Ginigival Depigmentation Procedure
A study testing depigmentation in people with Hyperpigmentation, run by Ain Shams University at 1 site in Egypt.
Trial summary
the investigator compares the clinical outcomes and pain levels after gingival depigmentation by ceramic soft tissue bur vs scalpel surgery Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hyperpigmentation
- What is being tested?
- depigmentation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Oct 2022to 10 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and females within age range of 20-50 years.
- Systemic (medically) free individuals.
- Gingival pigmentation score > 3 on Hedin melanin index15.
- Patients with good oral hygiene.
- Patients with thick gingival phenotype.
Who cannot join
- Smokers.
- Teeth with compromised periodontium.
- Pregnant and lactating females.
- The vulnerable group: patients with mental or physical disabilities.
- Medications that cause gingival pigmentation.
- Pathologies that cause gingival pigmentation.
Trial locations and contacts
1 site in 1 country.
About this study
the investigator compares the clinical outcomes and pain levels after gingival depigmentation by ceramic soft tissue bur vs scalpel surgery
Read the detailed description
This clinical study will be carried out to compare the efficacy of ceramic soft tissue trimming bur versus the conventional surgical scraping technique in the management of gingival hyperpigmentation.
This study will be conducted to assess:
Primary objectives:
- Clinical outcome of the gingival depigmentation procedure.
- Assessment of postoperative pain using the visual analogue scale.
- Patients' satisfaction will be assessed using the patient satisfaction questionnaire (short-form, PSQ-18) and the global aesthetic improvement scale.
Secondary objectives:
- Operating time.
- Wound healing.
- Conditions
- Hyperpigmentation
- Being tested
- depigmentation
- Medical subject headings
- Hyperpigmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
depigmentationProcedure or surgery
gingival depigmentation
| Study group | Role | What they receive |
|---|---|---|
| ceramic soft tissue bur | Experimental | Eight dental arches were treated by ceramic soft tissue bur Receives: Procedure: depigmentation |
| scalpel | Active comparator | Eight dental arches were treated by conventional scalpel technique Receives: Procedure: depigmentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical outcomes of depigmentation procedure
dummet oral pigmentation index ( DOPI): 1= pink no pigmentation (better) 4= deep brown (worse) Melanin index (MI):1= isolated pigment (better), 4= long continous ribbon (worse). reported by visual inspection.
Measured: 3 month postoperative
patient satisfaction
global aesthetic improvement scale 5 point likert scale 1= excellent improvement 5= worsened. patient reported outcome.
a score from 1 to 5, 1 being better
Measured: 3 months postoperative
Percieved pain
postoperative pain will be assessed using visual analoque scale (VAS): 1= being the least pain and 10= being the most severe
Measured: 7 days
Secondary outcomes (2)
operating time
time taken from the beginning of the procedure to its end by stopwatch
Measured: during surgery
Wound healing
- Complete reepithelialization
- Incomplete reepithelialization
- ulcer
- tissue defect or necrosis Dummet 1966
Measured: 7 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2023
- Study start10 Oct 2022
- Primary completion10 Apr 2023
- Study completion10 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperpigmentationStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- split mouth (dental arches)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sally Nassar, Ain Shams University
- Investigators
- Yasmine El sayed, Phd, Study director, Ain Shams UniversityHala Abu elela, Phd, Study chair, Ain Shams UniversitySally Nassar, Bds, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06031116
- Sponsor's protocol ID
- ceramic v blade depigmentation
- Status last verified
- Sep 2023
- First submitted
- 19 Dec 2022
- Last updated
- 11 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Ceramic Soft Tissue Trimming Bur Versus Conventional Scalpel Technique in Ginigival Depigmentation Procedure
- ClinicalTrials.gov ID
- NCT06031116
- Acronym / sponsor ID
- ceramic v blade depigmentation
- Conditions
- Hyperpigmentation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 10 Oct 2022 (actual)
- Primary completion
- 10 Apr 2023 (actual)
- Study completion
- 10 May 2023 (actual)
- First posted
- 11 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
the investigator compares the clinical outcomes and pain levels after gingival depigmentation by ceramic soft tissue bur vs scalpel surgery
Detailed description
This clinical study will be carried out to compare the efficacy of ceramic soft tissue trimming bur versus the conventional surgical scraping technique in the management of gingival hyperpigmentation.
This study will be conducted to assess:
Primary objectives:
- Clinical outcome of the gingival depigmentation procedure.
- Assessment of postoperative pain using the visual analogue scale.
- Patients' satisfaction will be assessed using the patient satisfaction questionnaire (short-form, PSQ-18) and the global aesthetic improvement scale.
Secondary objectives:
- Operating time.
- Wound healing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- split mouth (dental arches)
| Arm | Type | Receives |
|---|---|---|
| ceramic soft tissue bur | Experimental | Procedure: depigmentationEight dental arches were treated by ceramic soft tissue bur |
| scalpel | Active comparator | Procedure: depigmentationEight dental arches were treated by conventional scalpel technique |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males and females within age range of 20-50 years.
- Systemic (medically) free individuals.
- Gingival pigmentation score > 3 on Hedin melanin index15.
- Patients with good oral hygiene.
- Patients with thick gingival phenotype.
Key exclusion criteria (6 listed)
- Smokers.
- Teeth with compromised periodontium.
- Pregnant and lactating females.
- The vulnerable group: patients with mental or physical disabilities.
- Medications that cause gingival pigmentation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| depigmentationgingival depigmentation | Procedure or surgery | ceramic soft tissue bur, scalpel |
Primary outcome
clinical outcomes of depigmentation procedure
Time frame: 3 month postoperative
dummet oral pigmentation index ( DOPI): 1= pink no pigmentation (better) 4= deep brown (worse) Melanin index (MI):1= isolated pigment (better), 4= long continous ribbon (worse). reported by visual inspection.
patient satisfaction
Time frame: 3 months postoperative
global aesthetic improvement scale 5 point likert scale 1= excellent improvement 5= worsened. patient reported outcome. a score from 1 to 5, 1 being better
Percieved pain
Time frame: 7 days
postoperative pain will be assessed using visual analoque scale (VAS): 1= being the least pain and 10= being the most severe
2 secondary outcomes
operating time
Time frame: during surgery
Wound healing
Time frame: 7 days postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yasmine El sayed, Phd study director
Ain Shams University
Hala Abu elela, Phd study chair
Ain Shams University
Sally Nassar, Bds principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing depigmentation in people with Hyperpigmentation, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical outcomes of depigmentation procedure (time frame: 3 month postoperative). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2023.