Effect of Vitamin C on Collagen Production in Comparison to Hereditary Gingival Fibromatosis: Histopathological Study

NCT07043985 | Completed

• 1 other identifier: BUC-IACUC-250423-130
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

In this preliminary study, we propose that the intraepidermic injection of vit C can induce quantitative and qualitative modification of the gingival biotype. We also propose that such improvement is lacking of any pathologic transformation when will compare to the hereditary gingival fibromatosis with highlighting the mechanism of fibrous tissue formation. The study aims secondly to provide a detailed explanation for the pathogenesis of HGF.

Conditions

Tissue Modification After Vit c Injection

Outcome Measures

Primary Outcomes (1)

• Area percent occupied by connective tissue

  the percent of the tissues occupied by connective tissue only

  7

Secondary Outcomes (1)

• Density of Collagen bundles

  7

Study Arms (4)

G1 (positive control): 5 patients suffering from non-syndromic HGF

EXPERIMENTAL

Gingival bioposy was evaluated

Diagnostic Test: biopsy

G2 (negative control): 5 patients of normal healthy gingival tissue (negative control)

EXPERIMENTAL

normal healthy gingival tissue biopsy

Diagnostic Test: biopsy

received intraepidermic vitamin C injection for non-inflammatory purpose

ACTIVE COMPARATOR

vit C injection for non-inflammatory purpose

Diagnostic Test: biopsy

G4: 5 patients received vitamin C injection for inflammatory purposes

ACTIVE COMPARATOR

vitamin C injection for inflammatory purposes

Diagnostic Test: biopsy

Interventions

biopsy DIAGNOSTIC_TEST

Diagnosis of the HGF and healthy tissues depends on pre-described criteria; gingival overgrowth covering one third of the crown length as a minimum, systemically free, no history of drug uptake causing gingival overgrowth (nifedipine, phenytoin, cyclosporine, oral contraceptive pills). Before sampling, written consents were obtained from all patients. Using light microscope, haematoxylin and eosin (H\&E) stained sections were precisely examined and histopathological features were reported. All specimens were assessed semi-quantitatively, on a graded scale, under ×100 magnification power and a fixed grid for the following parameters. Three to four fields of each gingival specimen were randomly selected. A blinded evaluation was done by two independent observers. If a debate was reported regarding a specimen, a consensus was reached following re-evaluation. The most representative areas were selected to be morphometrically analyzed using Leica QWin 500 analyzer computer system (Germany).

G1 (positive control): 5 patients suffering from non-syndromic HGF; G2 (negative control): 5 patients of normal healthy gingival tissue (negative control); G4: 5 patients received vitamin C injection for inflammatory purposes; received intraepidermic vitamin C injection for non-inflammatory purpose

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• patients diagnosed as HGF
• patients diagnosed with altered passive eruption who needs excess gingival tissue removal
• no age or gender predilection

You may not qualify if:

• patienst undertaken drugs cause gingival enlargment
• prednent and lactating mothers

Sponsors & Collaborators

• Badr University: lead
• Cairo University: collaborator

Study Sites (1)

Entertainment Area, Badr City, Cairo, Egypt

Cairo, Egypt

Location

MeSH Terms

Interventions

Biopsy

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: June 17, 2025
• First Posted: June 29, 2025
• Study Start: January 3, 2018
• Primary Completion: November 5, 2024
• Study Completion: May 6, 2025
• Last Updated: June 29, 2025

Record last verified: 2025-06

Locations

EG (1)