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Comparative Evaluation of Vitamin C and Injectable-platelet Rich Fibrin in the Management of Thin Gingival Phenotype

NCT05841303 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2023-05-03

No results posted yet for this study

Summary

* The goal is to compare between the effect of vitamin C and Injectable-platelet rich fibrin in the management of thin gingival phenotype.
* The main question: ln patients with thin phenotype, will injecting Vitamin C with micro needles increase the gingival thickness compared to injecting injectable-platelet rich fibrin with micro needles?

* After enrolment, periodontal examination and measurement of periodontal probing depth (PD), patients with a high periodontal probe visibility in the anterior teeth will be identified. These patients will undergo gingival thickness (GT) measurement using trans gingival probing technique in the anterior teeth, and those with a measured GT of ≤ 1.5mm will be diagnosed with thin phenotype.
* Keratinized tissue width will be measured.
* Micro needle the gingival mucosa by using derma pen device which will be used in intermittent motion on the sextant gingival area for 30-40 seconds/tooth. When bleeding pinpoints observed on all areas of attached gingiva.

* Intervention group: Vitamin C injection will be injected with microneedle at two points for each site in the attached gingiva of right or left (split mouth) at 3 mm apical to the free gingival margin in the facial side of the tooth until the blanching of the gingiva will be seen and apical to the mucogingival junction.
* Control group:

1.Preparation and administration of injectable platelets rich fibrin (i-PRF). I-PRF will be injected on the site with thin gingival phenotype on the other side of the jaw in the same patient (split mouth technique) with micro needling same way as vitamin C group.

3.Vitamin C and I-PRF will again be injected at the same site after 1 week and after 2 weeks from the baseline final injection which will be given.

Outcomes: The results for the mean gingival thickness (GT), keratinized tissue width (kTW), pocket depth (PD), and gingival index (GI) at baseline, 1 month, 3 months and after 6 months

Conditions

  • Thin Gingival Biotype

Interventions

DRUG

Vit C

Vit c is proven to be an anti-inflammatory and antioxidant agent. also play a great role in collagen biosynthesis (collagen type I), as it helps in fibroblasts proliferation. It reduces the potentiality of scaring via inhibiting cross-linking of collagen fibers and fibrosis. It acts as a cofactor in hydroxyproline synthesis to produce collagen type IV and improves endothelial cell vitality and function..

OTHER

injectable PRF

5 ml of peripheral blood from each patient , blood will be transferred to a glass coated plastic vacutainer tube without anticoagulant. Then this tube will immediately centrifuged at 700 rpm for 3 mins \[Centrifuge Machine 5000rpm.After centrifugation, two fluid layers will formed, upper being yellow fluid layer (i-PRF) while lower layer containing red blood cells. Yellow fluid layer containing i-PRF will be immediately aspirated using micro needle to be injected for management of gingival phenotype

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • Riham M. Omar, Professor · Cairo University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-07-01
Primary Completion
2024-03-31
Completion
2024-11-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05841303 on ClinicalTrials.gov