Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-26 @ 2:09 AM
Study NCT ID:
NCT06312605
Status:
RECRUITING
Last Update Posted:
2024-03-15
First Post:
2024-03-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Adjunctive Role of Vitamin C on Pigment Recurrence (Randomized Clinical and Histological Trial)
Sponsor:
Ain Shams University
Organization:
Study Overview
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)
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
* 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.
* 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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: