Gingival PigmentationPhase 4NCT06312605
The Adjunctive Role of Vitamin C on Pigment Recurrence (Randomized Clinical and Histological Trial)
A Phase 4 study testing Injectable applied vitamin C, Topical applied Vitamin C and Surgical depigmentation only in people with Gingival Pigmentation, run by Ain Shams University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to determine the role of vitamin C on recurrence of gingival pigment after patients who are healthy and esthetically concerned with it received surgical removal of this pigment. The main question[s] it aims to answer are: Pigment recurrence after one year. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Pigmentation
- What is being tested?
- Injectable applied vitamin C, Topical applied Vitamin C and Surgical depigmentation only
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2023to Aug 2024
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Both genders aged from 18-40. Systemically free patients from any disease as evidenced by the health questionnaire, using modified Cornell medical index and classified as ASA class I.
- Patients who were diagnosed to have physiological gingival melanin pigmentation on the maxillary or mandibular keratinized gingiva with Dummett oral pigmentation score 2 or more.
- Patients with thick gingival phenotype ≥ 1.5 mm.
Who cannot join
- Pregnant or lactating females Smokers (water pipe, cigar or cigarette smoking). Patients taking or have taken any drug that may cause gingival depigmentation as chloroquine, minocycline, zidovudine, chlorpromazine, ketoconazole and bleomycin .
- Any cause for supplemental intake of vitamin C. Reported allergy to ascorbic acid or to any of its derivatives as reported in health questionnaire .
- Clinically diagnosed periodontitis regarding the following criteria probing depth >3mm, clinical attachment loss ≥ 1mm and bleeding on probing > 10% .
- Patients with poor oral hygiene, incompliant to treatment and persistence gingival inflammation after phase I periodontal therapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patient Response and Recurrence Rate Following Adjunctive Intra-Mucosal or Topical Ascorbic Acid To Gingival Depigmentation Using Surgical Scalpel Technique: (Randomized Clinical and Histological Trial)
The goal of this clinical trial is to determine the role of vitamin C on recurrence of gingival pigment after patients who are healthy and esthetically concerned with it received surgical removal of this pigment. The main question[s] it aims to answer are:
- Pigment recurrence after one year.
- Patient satisfaction and histological response of tissues.
Participants will be asked to come on regular follow up visits one group will receive vitamin C injection other will be asked to apply topical vitamin C on a specific regimen.
Researcher will compare the groups who received injectable vitamin C with those who topically applied it to see the effect of each.
Read the detailed description
Esthetic dentistry is currently concerned with the pivotal role of the gingival tissue along with the teeth color, shape and position to achieve a harmonious attractive smile.
Physiological gingival hyperpigmentation is attributed to the increased activity of melanocytes rather than the increased number; consequently the gingiva in these individuals reveals increased density of melanophores. There are several pigments that contribute to physiological gingival hyper pigmentation, the main contributory pigment is melanin that is synthesized by melanocytes. Melanocytes form melanosomes granules from the amino acid tyrosine converting it into a molecule called dehydroxyphenylalanine (DOPA) through a hydroxylation process catalyzed by tryosinase enzyme.
Surgical and non-surgical approaches have been utilized to treat gingival hyperpigmentation. De-epithelizing of the target region is the main concept for most of the surgical interventions using different techniques as de-epithelizing using surgical blade or bur abrasion, cryosurgery and laser.
Among the minimal invasive non-surgical approaches of treating gingival hyperpigmentation was vitamin C that yielded promising results in the previous few years as proved in different clinical trials and have been recently documented in systemic review by .Vitamin C binds to melanin effectively once introduced into the tissues with a consequent deficient in calcium and copper affecting both melanin formation and transportation.
One of the main challenges after treating gingival hyperpigmentation is pigment recurrence. Different theories tried to explain the reasons for recurrence, some attributed it to the three dimensional shape of rete pegs, others attributed it to the migration theory and capability of cells to migrate from existing neighboring areas . Recurrence of pigment had shown to be inevitable occurring with nearly equal ranges in the previously illustrated techniques.
Sheel et al illustrated no recurrence of gingival pigmentation was observed after 9 months follow up with the topical application of vitamin C after surgical gingival depigmentation in a case report. This case report highlighted the ancillary role of vitamin C in decreasing the recurrence rate of gingival pigment after depigmentation.
According to the researcher knowledge, up to this time, there were no further studies investigating the long-term effect of using vitamin C to gain gingival color stability after depigmentation. This study was conducted to compare efficacy of vitamin C either locally injected or topically applied after surgical gingival depigmentation on recurrence of pigment and patient satisfaction over one-year follow up.
- Conditions
- Gingival Pigmentation
- Being tested
- Injectable applied vitamin C, Topical applied Vitamin C, Surgical depigmentation only
- Keywords
- Gingival pigmentation /Pigment recurrence /Vitamin C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injectable applied vitamin CProcedure or surgery
Surgical gingival depigmentation is done for all participants, after then they receive injectable vitamin C
Topical applied Vitamin CProcedure or surgery
Surgical gingival depigmentation is done for all participants, after then they are instructed to apply topical vitamin C
Surgical depigmentation onlyProcedure or surgery
Surgical gingival depigmentation only without any drug
| Study group | Role | What they receive |
|---|---|---|
| Intramucosal vitamin C injection | Active comparator | After surgical gingival depigmentation, injectable vitamin C (Redox C 500 mg) using insulin syringe(29 Gauge 1cc 0.33mm x 8mm 5/16 needle) is applied at gingival sites 0.1 ml for each point that should be 3 mm. The regimen is done once weekly for a month then once a month for additional 5 months. Receives: Procedure: Injectable applied vitamin C |
| (Vitamin C topical gel | Active comparator | After surgical gingival depigmentation, patients in this group apply ascorbic acid containing gel prepared by Nawah Scientific Research Center. The micro emulsion was prepared by mixing tween 20 (4.66% w/w) as surfactant and isopropanol (2.3% w/w) as co-surfactant using magnetic stirring then diluted drop-wise with Vitamin C solution in water (10% w/w). The formed micro emulsion was then converted into gel using Poloxamer 407 (20% w/w) that was added at 4°C under continuous magnetic stirring Receives: Procedure: Topical applied Vitamin C |
| Control group | Placebo comparator | Surgical gingival depigmentation is carried out for these patients Receives: Procedure: Surgical depigmentation only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pigmentation scores
Dummet oral pigmentation index (DOPI) ,score (0-3), 0 = pink tissue [no clinical pigmentation]; 1 = mild light brown tissue [mild clinical pigmentation]; 2 = medium brown or mixed brown and pink tissue [moderate clinical pigmentation]; or 3 = deep brown/ blue-black tissue (heavy clinical pigmentation)
Measured: baseline (immediately before surgical depigmentation), one month, three months, six months, nine months and finally after 12 months post operatively
Assessment of pigment surface area (SA)
Standardized photos are taken and introduced into image J software after cropping interest area to calculate surface area of the pigment
Measured: baseline (immediately before surgical depigmentation), one month, three months, six months, nine months and finally after 12 months post operatively
Assessment of pigment intensity in terms of mean darkness value (MDV)
Standardized photos are taken and introduced into image J software after cropping interest area to calculate intensity of pigment
Measured: baseline (immediately before surgical depigmentation), one month, three months, six months, nine months and finally after 12 months post operatively
Secondary outcomes (2)
Patient satisfaction
Satisfaction questionnaire Question Scoring
Was the treatment painful?
- no pain; 2. Mild pain; 3. Severe pain
Did you notice a cosmetic change 1 week after the treatment? 1. not at all; 2. moderate; 3. marked
Did you notice a cosmetic change 6 week after the treatment?
- not at all; 2. moderate; 3. marked
Did the treatment your expectations? 1. no; 2. yes; 3. Over and above
Would you repeat the treatment if necessary?
- no; 2. yes; 3. Over and above
Measured: After 12 months
Histological response
Biopsies taken and stained with Fontana-Masson stain to calculate area fraction of the stained cells
Measured: baseline - 6 months -after a year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start1 Aug 2023
- Primary completionAug 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival PigmentationStudies 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
- All participants receive surgical depigmentation then either vitamin C is applied following 2 regimens
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Osama Mohamed Hashem, Ain Shams University
- Investigators
- Hala K. Abd-El-Gaber, Professor, Principal investigator, Professor of Oral Medicine, Oral Diagnosis and Periodontology Faculty of Dentistry - Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06312605
- Sponsor's protocol ID
- 230620
- Status last verified
- Mar 2024
- First submitted
- 9 Mar 2024
- Last updated
- 15 Mar 2024
- 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 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Response and Recurrence Rate Following Adjunctive Intra-Mucosal or Topical Ascorbic Acid To Gingival Depigmentation Using Surgical Scalpel Technique: (Randomized Clinical and Histological Trial)
- ClinicalTrials.gov ID
- NCT06312605
- Acronym / sponsor ID
- 230620
- Conditions
- Gingival Pigmentation
- Keywords
- Gingival pigmentation /Pigment recurrence /Vitamin C
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 15 Mar 2024 (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 goal of this clinical trial is to determine the role of vitamin C on recurrence of gingival pigment after patients who are healthy and esthetically concerned with it received surgical removal of this pigment. The main question[s] it aims to answer are:
- Pigment recurrence after one year.
- Patient satisfaction and histological response of tissues.
Participants will be asked to come on regular follow up visits one group will receive vitamin C injection other will be asked to apply topical vitamin C on a specific regimen.
Researcher will compare the groups who received injectable vitamin C with those who topically applied it to see the effect of each.
Detailed description
Esthetic dentistry is currently concerned with the pivotal role of the gingival tissue along with the teeth color, shape and position to achieve a harmonious attractive smile.
Physiological gingival hyperpigmentation is attributed to the increased activity of melanocytes rather than the increased number; consequently the gingiva in these individuals reveals increased density of melanophores. There are several pigments that contribute to physiological gingival hyper pigmentation, the main contributory pigment is melanin that is synthesized by melanocytes. Melanocytes form melanosomes granules from the amino acid tyrosine converting it into a molecule called dehydroxyphenylalanine (DOPA) through a hydroxylation process catalyzed by tryosinase enzyme.
Surgical and non-surgical approaches have been utilized to treat gingival hyperpigmentation. De-epithelizing of the target region is the main concept for most of the surgical interventions using different techniques as de-epithelizing using surgical blade or bur abrasion, cryosurgery and laser.
Among the minimal invasive non-surgical approaches of treating gingival hyperpigmentation was vitamin C that yielded promising results in the previous few years as proved in different clinical trials and have been recently documented in systemic review by .Vitamin C binds to melanin effectively once introduced into the tissues with a consequent deficient in calcium and copper affecting both melanin formation and transportation.
One of the main challenges after treating gingival hyperpigmentation is pigment recurrence. Different theories tried to explain the reasons for recurrence, some attributed it to the three dimensional shape of rete pegs, others attributed it to the migration theory and capability of cells to migrate from existing neighboring areas . Recurrence of pigment had shown to be inevitable occurring with nearly equal ranges in the previously illustrated techniques.
Sheel et al illustrated no recurrence of gingival pigmentation was observed after 9 months follow up with the topical application of vitamin C after surgical gingival depigmentation in a case report. This case report highlighted the ancillary role of vitamin C in decreasing the recurrence rate of gingival pigment after depigmentation.
According to the researcher knowledge, up to this time, there were no further studies investigating the long-term effect of using vitamin C to gain gingival color stability after depigmentation. This study was conducted to compare efficacy of vitamin C either locally injected or topically applied after surgical gingival depigmentation on recurrence of pigment and patient satisfaction over one-year follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- All participants receive surgical depigmentation then either vitamin C is applied following 2 regimens
| Arm | Type | Receives |
|---|---|---|
| Intramucosal vitamin C injection | Active comparator | Procedure: Injectable applied vitamin CAfter surgical gingival depigmentation, injectable vitamin C (Redox C 500 mg) using insulin syringe(29 Gauge 1cc 0.33mm x 8mm 5/16 needle) is applied at gingival sites 0.1 ml for each point that should be 3 mm. The regimen is done once weekly for a month then once a month for additional 5 months. |
| (Vitamin C topical gel | Active comparator | Procedure: Topical applied Vitamin CAfter surgical gingival depigmentation, patients in this group apply ascorbic acid containing gel prepared by Nawah Scientific Research Center. The micro emulsion was prepared by mixing tween 20 (4.66% w/w) as surfactant and isopropanol (2.3% w/w) as co-surfactant using magnetic stirring then diluted drop-wise with Vitamin C solution in water (10% w/w). The formed micro emulsion was then converted into gel using Poloxamer 407 (20% w/w) that was added at 4°C under continuous magnetic stirring |
| Control group | Placebo comparator | Procedure: Surgical depigmentation onlySurgical gingival depigmentation is carried out for these patients |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Both genders aged from 18-40. Systemically free patients from any disease as evidenced by the health questionnaire, using modified Cornell medical index and classified as ASA class I.
- Patients who were diagnosed to have physiological gingival melanin pigmentation on the maxillary or mandibular keratinized gingiva with Dummett oral pigmentation score 2 or more.
- Patients with thick gingival phenotype ≥ 1.5 mm.
Key exclusion criteria (4 listed)
- Pregnant or lactating females Smokers (water pipe, cigar or cigarette smoking). Patients taking or have taken any drug that may cause gingival depigmentation as chloroquine, minocycline, zidovudine, chlorpromazine, ketoconazole and bleomycin .
- Any cause for supplemental intake of vitamin C. Reported allergy to ascorbic acid or to any of its derivatives as reported in health questionnaire .
- Clinically diagnosed periodontitis regarding the following criteria probing depth >3mm, clinical attachment loss ≥ 1mm and bleeding on probing > 10% .
- Patients with poor oral hygiene, incompliant to treatment and persistence gingival inflammation after phase I periodontal therapy.
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 |
|---|---|---|
| Injectable applied vitamin CSurgical gingival depigmentation is done for all participants, after then they receive injectable vitamin C | Procedure or surgery | Intramucosal vitamin C injection |
| Topical applied Vitamin CSurgical gingival depigmentation is done for all participants, after then they are instructed to apply topical vitamin C | Procedure or surgery | (Vitamin C topical gel |
| Surgical depigmentation onlySurgical gingival depigmentation only without any drug | Procedure or surgery | Control group |
Primary outcome
Pigmentation scores
Time frame: baseline (immediately before surgical depigmentation), one month, three months, six months, nine months and finally after 12 months post operatively
Dummet oral pigmentation index (DOPI) ,score (0-3), 0 = pink tissue [no clinical pigmentation]; 1 = mild light brown tissue [mild clinical pigmentation]; 2 = medium brown or mixed brown and pink tissue [moderate clinical pigmentation]; or 3 = deep brown/ blue-black tissue (heavy clinical pigmentation)
Assessment of pigment surface area (SA)
Time frame: baseline (immediately before surgical depigmentation), one month, three months, six months, nine months and finally after 12 months post operatively
Standardized photos are taken and introduced into image J software after cropping interest area to calculate surface area of the pigment
Assessment of pigment intensity in terms of mean darkness value (MDV)
Time frame: baseline (immediately before surgical depigmentation), one month, three months, six months, nine months and finally after 12 months post operatively
Standardized photos are taken and introduced into image J software after cropping interest area to calculate intensity of pigment
2 secondary outcomes
Patient satisfaction
Time frame: After 12 months
Histological response
Time frame: baseline - 6 months -after a year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Efficacy of surgical laser therapy in the management of oral pigmented lesions: A systematic reviewLink provided by the sponsor.
- Gingival Depigmentation Using Scalpel Technique: A Case ReportLink provided by the sponsor.
- An insight into gingival depigmentation techniques: The pros and consLink provided by the sponsor.
Related trials for Gingival Pigmentation
Not yet recruiting
Gingival Depigmentation Using a 940 nm Diode Laser Versus Ceramic Bur
Physiologic Gingival Melanin Pigmentation
Enrolling by invitationPhase 3
Evaluation of the Efficacy of Topical Application of Liquid Nitrogen and Ascorbic Acid in Treatment of Gingival Pigmentation
Gingival Pigmentation, Gingiival Hyperpigmentation
Not yet recruiting
Influence of Adjunctive Acids Use on Esthetic Outcomes of Gingival Melanin Depigmentation: A Periodontal-Operative Pilot Randomized Clinical Trial
Gingival Pigmentation
Recruiting
Effect of Co-enzyme Q10 and Vitamin C Alone or in Combination After a Surgical Gingival Depigmentation
Depigmentation Treatment, Depigmentation
RecruitingPhase 2
Gingival Hyperpigmentation Treatment
Gingival Pigmentation, Depigmentation
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.
Hala K. Abd-El-Gaber, Professor principal investigator
Professor of Oral Medicine, Oral Diagnosis and Periodontology Faculty of Dentistry - 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 Phase 4 study testing Injectable applied vitamin C, Topical applied Vitamin C and Surgical depigmentation only in people with Gingival Pigmentation, 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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 15 Mar 2024. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eman O. Hashem, MSc (01025743781, emanemmy123456@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pigmentation scores (time frame: baseline (immediately before surgical depigmentation), one month, three months, six months, nine months and finally after 12 months post operatively). 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 15 Mar 2024.