Microneedling-Assisted Hyaluronic Acid for Interdental Papilla Deficiency
Microneedling-Assisted Hyaluronic Acid for Interdental Papilla Deficiency: Effects on Gingival Crevicular Fluid Biomarkers and Clinical Outcomes-A Randomized Controlled Clinical Trial
This randomized controlled clinical trial will evaluate whether microneedling combined with cross-linked hyaluronic acid injection provides superior reconstruction of interdental papilla deficiency compared with hyaluronic acid injection alone. Twenty participants with Nordland-Tarnow Class I or II interdental papilla deficiency will be randomly allocated into two parallel groups. The test group will receive microneedling followed by submucosal injection of cross-linked hyaluronic acid, while the control group will receive cross-linked hyaluronic acid injection alone. Three treatment sessions will be performed at 4-week intervals. Participants will be followed for 6 months. The primary outcome will be change in black triangle height. Secondary outcomes will include gingival crevicular fluid levels of MMP-9, TIMP-1 and periostin, plaque index, gingival index, periodontal probing depth, and patient satisfaction.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Young adult patients aged .
- Presence of at least one interdental papilla defect classified as Nordland-Tarnow Class I or II.
- Distance between the contact point and the interproximal bone crest ≤7 mm.
- No open contact between the affected teeth.
- Full-mouth periodontal treatment completed prior to enrollment.
- Willingness to participate and ability to provide written informed consent.
Exclusion Criteria:
- Systemic conditions affecting wound healing, soft tissue turnover, or immune response, including uncontrolled diabetes mellitus, immunosuppression, or coagulation disorders.
- Current use of anticoagulants, systemic corticosteroids, bisphosphonates, or medications known to affect gingival tissue or bone metabolism.
- Known hypersensitivity or allergy to hyaluronic acid or any component of the injectable preparation.
- Pregnancy or breastfeeding.
- Active periodontal disease.
- Nordland-Tarnow Class III papilla loss at the study site.
- Previous soft tissue augmentation procedures, surgical or injectable, at the study site.
- Use of any local or systemic anti-inflammatory medication within 3 months before enrollment.
- Smokers.
- Presence of restorations, crowns, veneers, or orthodontic brackets at or adjacent to the study site.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Microneedling + Hyaluronic Acid (MN+HA)
Participants will receive microneedling of the interdental papilla followed by submucosal injection of cross-linked hyaluronic acid. Three treatment sessions will be performed at 4-week intervals. |
A sterile disposable microneedling device will be applied to the interdental papilla using controlled vertical and oblique strokes until uniform punctate bleeding is observed. Cross-linked hyaluronic acid will be administered by submucosal injection into the interdental papilla. Three treatment sessions will be performed at 4-week intervals. |
|
Comparador Ativo: Hyaluronic Acid (HA)
Participants will receive submucosal injection of cross-linked hyaluronic acid without preceding microneedling. Three treatment sessions will be performed at 4-week intervals. |
Cross-linked hyaluronic acid will be administered by submucosal injection into the interdental papilla. Three treatment sessions will be performed at 4-week intervals. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Black Triangle Height
Prazo: Baseline, 1 month, 3 months, and 6 months
|
Black triangle height will be measured in millimeters as the linear distance from the base of the interproximal contact point to the most coronal tip of the interdental papilla using a calibrated UNC-15 periodontal probe. Standardized acrylic stents will be used to ensure reproducible probe angulation and reference point positioning. |
Baseline, 1 month, 3 months, and 6 months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Gingival Crevicular Fluid Periostin Level
Prazo: Baseline, 1 month, 3 months, and 6 months
|
Periostin concentration in gingival crevicular fluid will be measured using a commercially available human periostin ELISA kit. |
Baseline, 1 month, 3 months, and 6 months
|
|
Gingival Crevicular Fluid MMP-9 Level
Prazo: Baseline, 1 month, 3 months, and 6 months
|
MMP-9 concentration in gingival crevicular fluid will be measured using a commercially available human MMP-9 ELISA kit. |
Baseline, 1 month, 3 months, and 6 months
|
|
Gingival Crevicular Fluid TIMP-1 Level
Prazo: Baseline, 1 month, 3 months, and 6 months
|
TIMP-1 concentration in gingival crevicular fluid will be measured using a commercially available human TIMP-1 ELISA kit. |
Baseline, 1 month, 3 months, and 6 months
|
|
Plaque Index
Prazo: Baseline, 1 month, 3 months, and 6 months
|
Plaque accumulation will be assessed using the Silness and Löe Plaque Index on a score from 0 to 3. |
Baseline, 1 month, 3 months, and 6 months
|
|
Gingival Index
Prazo: Baseline, 1 month, 3 months, and 6 months
|
Gingival inflammation will be assessed using the Löe and Silness Gingival Index on a score from 0 to 3. |
Baseline, 1 month, 3 months, and 6 months
|
|
Periodontal Probing Depth
Prazo: Baseline, 1 month, 3 months, and 6 months
|
Periodontal probing depth will be measured in millimeters from the gingival margin to the base of the sulcus or periodontal pocket using a UNC-15 periodontal probe. |
Baseline, 1 month, 3 months, and 6 months
|
|
Patient Satisfaction
Prazo: 6 months
|
Patient satisfaction with esthetic appearance will be assessed using a visual analogue scale at the end of the follow-up period. |
6 months
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- BUC-IACUC-260517-185
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