Active Oxygen Gel Versus Hyaluronic Acid Gel for Palatal Wound Healing After Free Gingival Graft (OXYHA-FGG)
Effectiveness of Active Oxygen Gel Versus Hyaluronic Acid Gel on Palatal Wound Healing After Free Gingival Graft: A Randomized Controlled Clinical Trial
This randomized controlled clinical trial aims to evaluate and compare the effectiveness of different palatal dressing materials on wound healing following free gingival graft harvesting.
Thirty systemically healthy patients with mucogingival defects requiring free gingival graft procedures will be enrolled from the outpatient clinic of the Department of Oral Medicine and Periodontology, Faculty of Dentistry, Suez Canal University. Patients will be randomly allocated into three equal groups (10 patients each). Group A (control) will receive a gelatin sponge with flowable composite on the donor site. Group B will receive hyaluronic acid gel covered with a gelatin sponge and flowable composite. Group C will receive active oxygen gel covered with a gelatin sponge and flowable composite.
Postoperative outcomes will be assessed in terms of pain (visual analog scale), analgesic consumption, clinical wound healing (Landry healing index), complete wound re-epithelialization (hydrogen peroxide test), dimensional changes of the wound, and occurrence of complications. Evaluations will be performed at baseline and during follow-up visits up to four weeks postoperatively.
The study aims to determine which dressing material provides better postoperative comfort and enhances palatal wound healing after free gingival graft procedures.
Visão geral do estudo
Status
Descrição detalhada
This study is a randomized controlled clinical trial designed to evaluate the effect of different palatal dressing materials on wound healing following free gingival graft harvesting.
The study will be conducted at the outpatient clinic of the Department of Oral Medicine and Periodontology, Faculty of Dentistry, Suez Canal University, after approval of the Research Ethics Committee and Faculty Council. Thirty systemically healthy patients diagnosed with mucogingival defects requiring free gingival graft procedures will be recruited according to predefined inclusion and exclusion criteria. All participants will sign an informed consent form prior to enrollment.
Patients will be randomly allocated into three equal groups (n = 10 per group) using a computer-generated randomization method. Group A (control group) will receive a gelatin sponge covered with flowable composite on the palatal donor site. Group B will receive hyaluronic acid gel covered with a gelatin sponge and flowable composite. Group C will receive active oxygen gel (Blue®m) covered with a gelatin sponge and flowable composite.
Free gingival grafts will be harvested using the classical Sullivan and Atkins technique. The grafts will be adapted and sutured at the recipient site using resorbable sutures. At the donor site, hemostasis will be achieved using pressure with adrenaline-soaked gauze, followed by application of the assigned dressing protocol for each group.
Postoperative care will include analgesics (Ibuprofen 600 mg as needed), chlorhexidine mouth rinse (0.12%) twice daily for two weeks, and standard postoperative instructions. Patients will be recalled after 1 week for evaluation and removal/reapplication of the dressing when indicated, and again at 2 and 4 weeks for follow-up assessments.
Outcome measures include postoperative pain assessed using a visual analog scale (VAS), total analgesic consumption, wound healing evaluated by Landry healing index, complete wound re-epithelialization assessed using hydrogen peroxide test, two-dimensional wound measurements, and recording of any postoperative complications.
Statistical analysis will be performed using appropriate tests including ANOVA or Kruskal-Wallis test for comparison among groups, and repeated measures analysis for longitudinal data. A p-value ≤ 0.05 will be considered statistically significant.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Ismailia Governorate
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Ismailia, Ismailia Governorate, Egito
- Recrutamento
- Faculty of Dentistry, Suez Canal University
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Contato:
- Shimaa Nasser
- Número de telefone: +201117286714
- E-mail: pgs.230036@dent.suez.edu.eg
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Contato:
- Shimaa Morsy
- Número de telefone: +20 12 2552703
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
Systemically healthy patients Age between 18 and 60 years Patients with mucogingival defects requiring free gingival graft Adequate palatal thickness (>3 mm) Cooperative and motivated patients Good oral hygiene compliance
Exclusion Criteria:
Systemic diseases that contraindicate surgical procedures Smokers Pregnant or lactating females Immunocompromised patients Patients undergoing chemotherapy or radiotherapy Poor oral hygiene or non-compliant patients Palatal infection
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Outro: Control group
Participants will receive a gelatin sponge covered with flowable composite applied to the palatal donor site after free gingival graft harvesting as the control dressing for wound management.
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Gelatin sponge covered with flowable composite applied to the palatal donor site after free gingival graft harvesting as the standard control dressing for wound management
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Experimental: Hyaluronic acid group
Participants will receive hyaluronic acid gel applied to the palatal donor site and covered with a gelatin sponge and flowable composite dressing after free gingival graft harvesting.
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Hyaluronic acid gel applied to the palatal donor site and covered with a gelatin sponge and flowable composite dressing after free gingival graft harvesting to enhance wound healing.
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Experimental: Active oxygen group (Blue®m)
Participants will receive active oxygen gel applied to the palatal donor site and covered with a gelatin sponge and flowable composite dressing after free gingival graft harvesting.
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Active oxygen gel applied to the palatal donor site and covered with a gelatin sponge and flowable composite dressing after free gingival graft harvesting to enhance wound healing.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Wound healing (Landry Healing Index)
Prazo: 1 week, 2 weeks, 3 weeks and 4 weeks postoperatively
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Assessment of palatal wound healing using the Landry Healing Index, which uses a score ranging from 1 to 5, with higher scores indicating better wound healing.
The assessment includes tissue color, response to palpation, bleeding, granulation tissue, incision margin, and suppuration.
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1 week, 2 weeks, 3 weeks and 4 weeks postoperatively
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Complete epithelialization (Hydrogen peroxide test)
Prazo: 1 week, 2 weeks, 3 weeks and 4 weeks postoperatively
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Assessment of complete wound epithelialization using hydrogen peroxide bubbling test.
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1 week, 2 weeks, 3 weeks and 4 weeks postoperatively
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Two-dimensional wound area reduction
Prazo: Baseline, 1 week, 2 weeks, 3 weeks and 4 weeks postoperatively
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Measurement of the palatal wound surface area (length × width) to assess two-dimensional reduction in wound size over time after free gingival graft harvesting.
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Baseline, 1 week, 2 weeks, 3 weeks and 4 weeks postoperatively
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Postoperative pain (VAS score)
Prazo: Daily for the first postoperative week (Day 1 to Day 7)
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Evaluation of postoperative pain using the Visual Analog Scale (VAS), ranging from 0 to 10, with higher scores indicating greater pain, after free gingival graft harvesting in the three study groups.
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Daily for the first postoperative week (Day 1 to Day 7)
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
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
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 919/2024
- suez canal university (Outro identificador: suez canal university)
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