Gingival HyperpigmentaionPhase 4NCT03252418
Ascorbic Acid Versus Diode Laser in the Treatment of Gingival Hyperpigmentation
A Phase 4 study testing Ascorbic Acid 500 MG and diode laser in people with Gingival Hyperpigmentaion, run by Ain Shams University.
Trial summary
Vitamin C affect the melanocytes function not the number while diode laser cause melanocytes destruction. Although diode laser and vitamin C have proved their effectiveness in depigmentation in previous studies, there are no published studies compared the effect of diode laser and vitamin C on melanocytes and… Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Gingival Hyperpigmentaion
- What is being tested?
- Ascorbic Acid 500 MG and diode laser
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 7 Oct 2015to 10 Sep 2016
- Phase
- Phase 4
- 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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and female patients with age ranging from 18 years old to 40 years old.
- Bilaterally symmetric gingival hyperpigmentation on the maxillary and mandibular labial keratinized gingiva between canines.
- Patients free from any systemic diseases as evidenced by the health questionnaire, using modified Cornell medical index (Pendleton et al., 2004).
- Patients with thick gingival biotype ≥ 3 mm.
Who cannot join
- Presence of local condition that may cause gingival hyperpigmentation (traumatized epithelium caused by defective fixed prosthesis or restoration).
- Smokers.
- Pregnant or lactating females.
- Patients with poor oral hygiene, incompliance to treatment and persistence gingival inflammation after phase I periodontal therapy.
- Clinically diagnosed periodontitis (attachment and bone loss, presence of periodontal pockets, gingival recession and tooth mobility).
- Previous treatment to pigmentation.
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- Patients taking supplementary vitamin C for any reason.
- Known sensitivity to ascorbic acid or any of its derivatives.
- Patients taking any drug that may cause gingival pigmentation.
About this study
Official title: Ascorbic Acid Versus Diode Laser in the Treatment of Gingival Hyperpigmentation: Histological and Clinical Randomized Study
Vitamin C affect the melanocytes function not the number while diode laser cause melanocytes destruction. Although diode laser and vitamin C have proved their effectiveness in depigmentation in previous studies, there are no published studies compared the effect of diode laser and vitamin C on melanocytes and melanosomes clinically and histologically.
Read the detailed description
Cosmetic dentistry is usually centered on aesthetic restorative procedures but it may also involve the appearance of the gingiva, especially when it is located in the anterior labial region. Oral pigmentation may be physiological or pathological in nature. Better esthetics results of depigmentation were achieved with diode laser than conventional scalpel and with rotary abrasion, also diode laser is effective and safe in removal of gingival hyperpigmentation and repigmentation doesn't occur.When choosing a depigmenting agent, it is important to differentiate between substances that are toxic to the melanocyte and substances that interrupt the key steps of melanogenesis. Vit. C interacts with copper ions at the tyrosinase-active site and inhibits action of the enzyme tyrosinase, thereby decreasing the melanin formation.
This randomized comparative clinical study was conducted on ten patients attending the outpatient clinic of the Oral Medicine and Periodontology department, Faculty of Dentistry, Ain Shams University and seeking treatment for their gingival hyperpigmentation for esthetic reason.
The study was conducted after receiving an ethical clearance from the Research Ethics Committee of Ain Shams University, Faculty of Dentistry; that the study follows the ethical guidelines of research. The patients clearly understood the purpose of this study and signed an informed consent.
According to the study results, vit C treated patients showed no or little repigmentation after six months post treatment. Conversely, diode laser treated patients showed significant recurrence of gingival pigmentation after six months post treatment. These could be attributed to the blocking effect of vitamin C on the existing melanocytes to form new melanoseomes, however diode laser cause removal of the existing melanocytes that may cause formation of new melanocytes (migrating from neighboring melanocytes from the adjacent area of the gingiva) with the ability of forming new melanosomes and causing repigmentation. Histopathological assessment revealed that both treatment modalities caused significant reduction in MAF after six months post treatment.
- Conditions
- Gingival Hyperpigmentaion
- Being tested
- Ascorbic Acid 500 MG, diode laser
- Keywords
- ascorbic acid, diode laser, gingival hyperpigmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ascorbic Acid 500 MGDrug
ascorbic acid is vitamin that can cause gingival depigmentation
diode laserDevice
diode laser is soft tissue laser case photothermolysis of melanoctes
| Study group | Role | What they receive |
|---|---|---|
| ascorbic acid | Experimental | injection of 1 ml intamucosal ascorbic acid 3 times with 1 week interval Receives: Drug: Ascorbic Acid 500 MG |
| diode laser | Experimental | photothermolysis by diode laser in one session Receives: Device: diode laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dummett oral pigmentaion index (DOPI)
scoring from 0 ( no pigmentation to 3 (sever pigmentation
Measured: change from baseline to 1, 3 and 6 months
gingival brightness (ΔL)
using spectrophotometer
Measured: change from baseline to 1, 3 and 6 months
histological mean area fraction of melanosomes
by taking soft tissue samples and stained by fontana masson stain
Measured: change from baseline to 6 months
Secondary outcomes (1)
patient satisfaction questionnaire
from scoring patients pain and cosmetic changes
Measured: immediate postopearive, 1 week, 1 month and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2017
- Study start7 Oct 2015
- Primary completion10 Sep 2016
- Study completion10 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival HyperpigmentaionStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- treating of gingival hyperpigmentation by two different methods
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dalia Yosri, Ain Shams University
- Investigators
- Nevine H kheir ElDien, Professor, Study director, faculty of Dentistry- Ain Shams univesity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03252418
- Sponsor's protocol ID
- FDASU-RECIM10201512
- Status last verified
- Aug 2017
- First submitted
- 15 Aug 2017
- Last updated
- 22 Aug 2017
- 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 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ascorbic Acid Versus Diode Laser in the Treatment of Gingival Hyperpigmentation: Histological and Clinical Randomized Study
- ClinicalTrials.gov ID
- NCT03252418
- Acronym / sponsor ID
- FDASU-RECIM10201512
- Conditions
- Gingival Hyperpigmentaion
- Keywords
- ascorbic acid, diode laser, gingival hyperpigmentation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 7 Oct 2015 (actual)
- Primary completion
- 10 Sep 2016 (actual)
- Study completion
- 10 Sep 2016 (actual)
- First posted
- 17 Aug 2017 (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.
Vitamin C affect the melanocytes function not the number while diode laser cause melanocytes destruction. Although diode laser and vitamin C have proved their effectiveness in depigmentation in previous studies, there are no published studies compared the effect of diode laser and vitamin C on melanocytes and melanosomes clinically and histologically.
Detailed description
Cosmetic dentistry is usually centered on aesthetic restorative procedures but it may also involve the appearance of the gingiva, especially when it is located in the anterior labial region. Oral pigmentation may be physiological or pathological in nature. Better esthetics results of depigmentation were achieved with diode laser than conventional scalpel and with rotary abrasion, also diode laser is effective and safe in removal of gingival hyperpigmentation and repigmentation doesn't occur.When choosing a depigmenting agent, it is important to differentiate between substances that are toxic to the melanocyte and substances that interrupt the key steps of melanogenesis. Vit. C interacts with copper ions at the tyrosinase-active site and inhibits action of the enzyme tyrosinase, thereby decreasing the melanin formation.
This randomized comparative clinical study was conducted on ten patients attending the outpatient clinic of the Oral Medicine and Periodontology department, Faculty of Dentistry, Ain Shams University and seeking treatment for their gingival hyperpigmentation for esthetic reason.
The study was conducted after receiving an ethical clearance from the Research Ethics Committee of Ain Shams University, Faculty of Dentistry; that the study follows the ethical guidelines of research. The patients clearly understood the purpose of this study and signed an informed consent.
According to the study results, vit C treated patients showed no or little repigmentation after six months post treatment. Conversely, diode laser treated patients showed significant recurrence of gingival pigmentation after six months post treatment. These could be attributed to the blocking effect of vitamin C on the existing melanocytes to form new melanoseomes, however diode laser cause removal of the existing melanocytes that may cause formation of new melanocytes (migrating from neighboring melanocytes from the adjacent area of the gingiva) with the ability of forming new melanosomes and causing repigmentation. Histopathological assessment revealed that both treatment modalities caused significant reduction in MAF after six months post treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- treating of gingival hyperpigmentation by two different methods
| Arm | Type | Receives |
|---|---|---|
| ascorbic acid | Experimental | Drug: Ascorbic Acid 500 MGinjection of 1 ml intamucosal ascorbic acid 3 times with 1 week interval |
| diode laser | Experimental | Device: diode laserphotothermolysis by diode laser in one session |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male and female patients with age ranging from 18 years old to 40 years old.
- Bilaterally symmetric gingival hyperpigmentation on the maxillary and mandibular labial keratinized gingiva between canines.
- Patients free from any systemic diseases as evidenced by the health questionnaire, using modified Cornell medical index (Pendleton et al., 2004).
- Patients with thick gingival biotype ≥ 3 mm.
Key exclusion criteria (9 listed)
- Presence of local condition that may cause gingival hyperpigmentation (traumatized epithelium caused by defective fixed prosthesis or restoration).
- Smokers.
- Pregnant or lactating females.
- Patients with poor oral hygiene, incompliance to treatment and persistence gingival inflammation after phase I periodontal therapy.
- Clinically diagnosed periodontitis (attachment and bone loss, presence of periodontal pockets, gingival recession and tooth mobility).
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 |
|---|---|---|
| Ascorbic Acid 500 MGascorbic acid is vitamin that can cause gingival depigmentation | Drug | ascorbic acid |
| diode laserdiode laser is soft tissue laser case photothermolysis of melanoctes | Device | diode laser |
Primary outcome
Dummett oral pigmentaion index (DOPI)
Time frame: change from baseline to 1, 3 and 6 months
scoring from 0 ( no pigmentation to 3 (sever pigmentation
gingival brightness (ΔL)
Time frame: change from baseline to 1, 3 and 6 months
using spectrophotometer
histological mean area fraction of melanosomes
Time frame: change from baseline to 6 months
by taking soft tissue samples and stained by fontana masson stain
1 secondary outcome
patient satisfaction questionnaire
Time frame: immediate postopearive, 1 week, 1 month and 6 months
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 22 Aug 2017.
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Active, not recruitingPhase 1/2
Effectiveness of Omega-3 Poly Unsaturated Fatty Acids on The Treatment of Gingival Hyperpigmentation
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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.
Nevine H kheir ElDien, Professor study director
faculty of Dentistry- Ain Shams univesity
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ascorbic Acid 500 MG and diode laser in people with Gingival Hyperpigmentaion, run by Ain Shams University.
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 4 inclusion and 9 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 22 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Dummett oral pigmentaion index (DOPI) (time frame: change from baseline to 1, 3 and 6 months). 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 22 Aug 2017.