Thin Gingival Phenotype
Conditions
Keywords
Gingival phenotype, Gingival thickness, Keratinized tissue width, Gingival augmentation, Injectable platelet-rich fibrin, Microneedling, Vitamin C
Brief summary
This randomized split-mouth clinical trial will evaluate whether adding locally injected vitamin C to injectable platelet-rich fibrin (i-PRF) and microneedling improves gingival tissue thickness and keratinized tissue width in women with a thin gingival phenotype in the lower front teeth region. Each participant will receive i-PRF and microneedling on both sides of the lower anterior region. One side will additionally receive vitamin C, while the opposite side will receive normal saline as a placebo. The treatment will be repeated after 4 weeks. Gingival measurements will be taken at baseline, 3 months, and 6 months after the second treatment session. Patient satisfaction will also be assessed during follow-up.
Detailed description
This study is a randomized, triple-blinded, split-mouth controlled clinical trial conducted in the Master Clinic of Periodontology at the University of Science and Technology, Aden, Yemen. The study will include female participants aged 18-65 years with a thin gingival phenotype in the anterior mandibular region. Both sides of the mandibular anterior region will receive microneedling followed by injectable platelet-rich fibrin (i-PRF). On the test side, locally administered vitamin C will be given as a separate sequential injection in close proximity to the i-PRF injection site within the same treatment zone. On the control side, normal saline will be administered in the same manner as placebo. The intervention will be repeated after 4 weeks. Gingival thickness and keratinized tissue width will be assessed at baseline and during follow-up at 3 and 6 months after the second treatment session. The study will also assess the stability of gingival augmentation over time and patient-reported esthetic satisfaction.
Interventions
DRUGVitamin C
Vitamin C will be administered locally on the test side as a separate sequential injection in close proximity to the i-PRF injection site within the same treatment zone. The injection will be given after microneedling and i-PRF administration and repeated after 4 weeks. The final concentration and injection volume will follow the finalized study protocol.
DRUGNormal Saline Placebo
Normal saline will be administered locally on the control side as a placebo, using the same route and timing as the vitamin C injection. It will be given as a separate sequential injection in close proximity to the i-PRF injection site within the same treatment zone and repeated after 4 weeks.
BIOLOGICALInjectable Platelet-Rich Fibrin (i-PRF)
Approximately 10 mL of venous blood will be collected in a sterile tube without anticoagulant and centrifuged at 700 revolution per minute for 3 minutes. The upper liquid platelet- and leukocyte-rich fraction will be aspirated and injected submucosally into both sides of the mandibular anterior region, approximately 3 mm apical to the free gingival margin. The procedure will be repeated after 4 weeks.
PROCEDUREMicroneedling
Microneedling will be performed on both sides of the mandibular anterior region using a Derma Pen M8 with an 18-needle cartridge at a depth of 1 mm and a speed of 700 cycles per minute. Vertical stamping will be applied for approximately 30-40 seconds per tooth until pinpoint bleeding is achieved. The procedure will be performed at baseline and repeated after 4 weeks.
Sponsors
University of Science and Technology, Yemen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
Participants, the treating operator, and the outcome assessor will be blinded to treatment allocation. Vitamin C and normal saline will be provided in coded syringes labeled A and B, and the allocation code will remain concealed during treatment and outcome assessment.
Intervention model description
Randomized split-mouth design in which each participant receives both interventions concurrently on contralateral sides of the mandibular anterior region. One side is randomly assigned to i-PRF plus microneedling and vitamin C, while the opposite side receives i-PRF plus microneedling and normal saline placebo.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Systemically healthy female participants. * Age 18 to 65 years. * Thin gingival phenotype (\<1.5 mm). * No known blood disorders. * Good oral hygiene.
Exclusion criteria
* Pregnancy. * Use of medications known to cause gingival enlargement. * History of trauma from occlusion or bruxism. * Previous soft-tissue grafting or other periodontal soft-tissue surgery at the study sites. * Heavy smoking (\>10 cigarettes per day). * Known allergy or hypersensitivity to vitamin C. * Use of vitamin C supplementation within the previous 2 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Between-Side Difference in Change in Gingival Thickness From Baseline to 3 Months | Baseline and 3 months after the second treatment session | Gingival thickness will be measured at the mid-facial aspect of the mandibular anterior teeth, 3 mm apical to the free gingival margin, using direct transgingival measurement with a standardized endodontic instrument and digital caliper. For each participant, the change in gingival thickness from baseline to 3 months will be calculated separately for the vitamin C side and the placebo side. The paired between-side difference in change will then be compared. |
| Between-Side Difference in Change in Keratinized Tissue Width From Baseline to 3 Months | Baseline and 3 months after the second treatment session | Keratinized tissue width will be measured at the mid-facial aspect of the mandibular anterior teeth as the distance from the free gingival margin to the mucogingival junction using a University of North Carolina 15-mm (UNC-15) periodontal probe. For each participant, the change in keratinized tissue width from baseline to 3 months will be calculated separately for the vitamin C side and the placebo side. The paired between-side difference in change will then be compared. |
| Between-Side Difference in Change in Gingival Thickness From Baseline to 6 Months | Baseline and 6 months after the second treatment session | Gingival thickness will be measured at the mid-facial aspect of the mandibular anterior teeth, 3 mm apical to the free gingival margin, using direct transgingival measurement with a standardized endodontic instrument and digital caliper. For each participant, the change in gingival thickness from baseline to 6 months will be calculated separately for the vitamin C side and the placebo side. The paired between-side difference in change will then be compared. |
| Between-Side Difference in Change in Keratinized Tissue Width From Baseline to 6 Months | Baseline and 6 months after the second treatment session | Keratinized tissue width will be measured at the mid-facial aspect of the mandibular anterior teeth as the distance from the free gingival margin to the mucogingival junction using a University of North Carolina 15-mm (UNC-15) periodontal probe. For each participant, the change in keratinized tissue width from baseline to 6 months will be calculated separately for the vitamin C side and the placebo side. The paired between-side difference in change will then be compared. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Within-Side Change in Gingival Thickness From Baseline to 3 Months | Baseline and 3 months after the second treatment session | Gingival thickness will be measured at the mid-facial aspect of the mandibular anterior teeth, 3 mm apical to the free gingival margin, using direct transgingival measurement with a standardized endodontic instrument and digital caliper. The change in gingival thickness from baseline to 3 months will be evaluated separately within the vitamin C-treated side and the placebo-treated side. |
| Within-Side Change in Keratinized Tissue Width From Baseline to 3 Months | Baseline and 3 months after the second treatment session | Keratinized tissue width will be measured at the mid-facial aspect of the mandibular anterior teeth as the distance from the free gingival margin to the mucogingival junction using a University of North Carolina 15-mm (UNC-15) periodontal probe. The change in keratinized tissue width from baseline to 3 months will be evaluated separately within the vitamin C-treated side and the placebo-treated side. |
| Within-Side Change in Gingival Thickness From Baseline to 6 Months | Baseline and 6 months after the second treatment session | Gingival thickness will be measured at the mid-facial aspect of the mandibular anterior teeth, 3 mm apical to the free gingival margin, using direct transgingival measurement with a standardized endodontic instrument and digital caliper. The change in gingival thickness from baseline to 6 months will be evaluated separately within the vitamin C-treated side and the placebo-treated side. |
| Within-Side Change in Keratinized Tissue Width From Baseline to 6 Months | Baseline and 6 months after the second treatment session | Keratinized tissue width will be measured at the mid-facial aspect of the mandibular anterior teeth as the distance from the free gingival margin to the mucogingival junction using a University of North Carolina 15-mm (UNC-15) periodontal probe. The change in keratinized tissue width from baseline to 6 months will be evaluated separately within the vitamin C-treated side and the placebo-treated side. |
| Stability of Gingival Thickness From 3 to 6 Months | 3 and 6 months after the second treatment session | Gingival thickness will be measured at the mid-facial aspect of the mandibular anterior teeth, 3 mm apical to the free gingival margin, using direct transgingival measurement with a standardized endodontic instrument and digital caliper. Gingival thickness at 3 months will be compared with gingival thickness at 6 months within each treatment side to assess the stability of the achieved augmentation over time. |
| Stability of Keratinized Tissue Width From 3 to 6 Months | 3 and 6 months after the second treatment session | Keratinized tissue width will be measured at the mid-facial aspect of the mandibular anterior teeth as the distance from the free gingival margin to the mucogingival junction using a University of North Carolina 15-mm (UNC-15) periodontal probe. Keratinized tissue width at 3 months will be compared with keratinized tissue width at 6 months within each treatment side to assess the stability of the achieved augmentation over time. |
| Between-Side Difference in Patient-Reported Esthetic Satisfaction at 3 and 6 Months | 3 and 6 months after the second treatment session | Patient-reported esthetic satisfaction will be assessed separately for the vitamin C-treated side and the placebo-treated side using a standardized 5-point Likert scale. Scores for the two sides will be compared at 3 months and again at 6 months after the second treatment session. |
| Association Between Baseline Platelet Count and Change in Gingival Thickness | Baseline to 6 months after the second treatment session | Baseline platelet count will be obtained from the complete blood count performed before the intervention. The association between baseline platelet count and the change in gingival thickness from baseline to follow-up will be evaluated to determine whether platelet levels within the normal physiological range are related to the extent of gingival thickness enhancement. |
Countries
Yemen
Contacts
CONTACTAlaa M Al-Thwabi, BDS
PRINCIPAL_INVESTIGATORWaddah A Al-Hajj, PhD
University of Science and Technology, Aden, Yemen
Outcome results
None listed