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

NCT05841303 | Unknown Phase 4

• 1 other identifier: 13123PER 3_3_1
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Thin gingival biotype; Vitamin C; i-PRF; Microneedle

Outcome Measures

Primary Outcomes (1)

• Gingival thickness (GT) change from baseline to 6months.

  GT will be measured using a no. 15 endodontic spreader (the file will be inserted perpendicularly through the gingiva, 2 mm apical to the gingival margin through the soft tissue until a hard surface reached). The flowable light-curing composite will be used to mark the penetration thickness on the spreader. Then, caliper or endo. Ruler will be used to measure the penetration thickness between the spreader's tip and the light-cured composite.

  GT will be taken at baseline, 1 month, 3 months and 6months after the intervention during the follow-up period and will be done by a single calibrated examiner.

Secondary Outcomes (4)

• Keratinized tissue width (KTW) change from baseline to 6months.

  The KTW. will be taken at baseline, 1 month, 3 months and 6months after the intervention during the follow-up period and will be done by a single calibrated examiner.

• Gingival index (GI)change from baseline to 6months.

  GI. will be taken at baseline, 1 month, 3 months and 6months after the intervention during the follow-up period and will be done by a single calibrated examiner.

• Plaque index (PI) change from baseline to 6months.

  PI will be taken at baseline, 1 month, 3 months and 6months after the intervention during the follow-up period and will be done by a single calibrated examiner.

• Probing depth. (PD) change from baseline to 6months.

  PD. will be taken at baseline, 1 month, 3 months and 6months after the intervention during the follow-up period and will be done by a single calibrated examiner.

Study Arms (2)

Vit. C injection

EXPERIMENTAL

Derma pen device model M8 with 24 -micro needle will be adjusted with 1.5 mm depth at the 6th mode speed of 700 cycles/min with intermittent motion used on the sextant gingival area for 30-40 seconds/tooth. vitamin C will be injected with microneedle at two points for each site in the attached gingiva of one site of the jaw either the left or the right side 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. \- Vitamin C will again be injected at the same site after 1 week and after 2 weeks from the baseline final injection which will be given.

Drug: Vit C

Injectable-platelet Rich Fibrin (i-PRF)

ACTIVE COMPARATOR

The derma pen will be used same as vitamin C group. I-PRF will be immediately aspirated using micro needle. I-PRF will be injected on the site with thin gingival phenotype (split mouth technique) with micro needling with derma pen at two points for each site in the attached gingiva at 3 mm apical to the free gingival margin in the facial side of the tooth until the blanching of the gingiva was seen and apical to the mucogingival junction. 4\. 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.

Other: injectable PRF

Interventions

Vit C DRUG

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..

Also known as: Ascorbic acid

Vit. C injection

injectable PRF OTHER

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

Also known as: i-PRF

Injectable-platelet Rich Fibrin (i-PRF)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Systemically healthy individuals of age ≥ 18 to 40 years with absence of active periodontal disease.
• Having thin gingival phenotype \<1.5mm.
• No systemic disease according to Modified Cornell Medical Index health questionnaire.
• Non-smoker.
• Full mouth plaque index (PI) and full-mouth bleeding on probing (BOP) score of ≤ 15%.
• No malocclusion, crowding, fillings, missing or supernumerary mandibular anterior teeth.
• No blood-borne conditions.

You may not qualify if:

• Active orthodontic treatment.
• Previous periodontal surgery.
• Systemic disease.
• Use of blood thinners.
• Use of any drugs that might lead to gingival enlargement.
• Mucogingival stress, bruxism.
• Pregnancy or lactation.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of dentistry Cairo University

Cairo, Elmanil, 4240101, Egypt

Location

MeSH Terms

Interventions

Ascorbic Acid

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Officials

• Riham M. Omar, Professor

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

Noha M. Abdelhay, Bachelor

CONTACT

+02 01092989975; noha_mahmoud@dentistry.cu.edu.eg

Manar Elzanaty, Ass. Lecturer

CONTACT

manar.elzanaty@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Each site with thin gingival phenotype will be randomly allocated to either intervention group (vit. C with MN) or control group (I-PRF with MN). The allocation sequence will be concealed in opaque sealed envelopes, which will be identified with the initials of the patient's name. For each patient, the envelope will be opened immediately before the intervention. Patients will be blinded during the intervention and follow-up sessions. * The patients will be blinded * The operator will be blinded as investigator can give the operator the vial filled with either
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching assistant at periodontology department MTI University

Model Details: A Split-mouth Randomized Clinical Trial.

Study Record Dates

• First Submitted: April 7, 2023
• First Posted: May 3, 2023
• Study Start: July 1, 2023
• Primary Completion: March 31, 2024
• Study Completion: November 1, 2024
• Last Updated: May 3, 2023

Record last verified: 2023-04

Locations

EG (1)