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Early Loading of UV-Functionalized Dental Implants

3 de julho de 2026 atualizado por: Damascus University

Effect of Early Loading on Ultraviolet Photofunctionalized Dental Implants: A Randomized Controlled Triple-Blind Split-Mouth Clinical Trial

This randomized controlled triple-blind split-mouth clinical trial was conducted to evaluate the effect of early loading on ultraviolet photofunctionalized dental implants placed in the posterior mandible. Ten patients received a total of 20 implants, with each participant receiving one ultraviolet photofunctionalized implant and one non-photofunctionalized control implant. Ultraviolet photofunctionalization was performed 24 hours before implant placement by an independent investigator. All implants were early loaded 4 weeks after surgery. Implant stability was assessed using Resonance Frequency Analysis (RFA) and expressed as Implant Stability Quotient (ISQ) values at implant placement, 3 weeks, and 4 weeks after surgery. Peri-implant marginal bone loss was evaluated radiographically during a one-year follow-up period. The study compared implant stability and radiographic outcomes between ultraviolet photofunctionalized and conventional implants under early loading conditions.

Visão geral do estudo

Descrição detalhada

Dental implants have become a predictable and widely accepted treatment modality for the rehabilitation of partially and completely edentulous patients.

Successful implant therapy depends largely on achieving and maintaining osseointegration between the implant surface and the surrounding bone. Traditionally, implants were left unloaded for several months to allow sufficient healing and osseointegration before functional loading. However, the growing demand for shorter treatment times has encouraged the development of early loading protocols. Early loading of dental implants offers several clinical advantages, including reduced treatment duration, earlier restoration of function and esthetics, and improved patient satisfaction. Nevertheless, successful early loading requires adequate implant stability during the critical healing period. Consequently, considerable research has focused on improving implant surface characteristics to accelerate osseointegration and enhance implant stability. Ultraviolet (UV) photofunctionalization is a surface modification technique that involves exposing titanium implants to ultraviolet light before placement. This process reduces hydrocarbon contamination on the implant surface, increases surface hydrophilicity, and enhances the biological activity of titanium. Previous experimental and clinical studies have suggested that UV photofunctionalization may improve cell attachment, promote bone formation, increase bone-to-implant contact, and enhance implant stability during the early stages of healing. This randomized controlled triple-blind split-mouth clinical trial was conducted to evaluate the effect of early loading on ultraviolet photofunctionalized dental implants placed in the posterior mandible. Ten patients requiring bilateral implant-supported rehabilitation in comparable posterior mandibular sites were included. A total of twenty implants were placed, with each participant receiving one ultraviolet photofunctionalized implant and one non photofunctionalized control implant. Implant allocation was randomized, and ultraviolet photofunctionalization was performed by an independent investigator 24 hours before surgery. Participants, the surgeon/outcome assessor, and the statistician were blinded to treatment allocation throughout the study. All implants were restored using an early loading protocol four weeks after implant placement. Implant stability was evaluated using Resonance Frequency Analysis (RFA) and expressed as Implant Stability Quotient (ISQ) values. Measurements were obtained at implant placement, three weeks after surgery, and four weeks after surgery. In addition, peri-implant marginal bone loss was assessed radiographically during a one-year follow-up period. The split-mouth design was selected to minimize inter-individual variability and allow direct comparison between test and control implants within the same participant. The study aimed to determine whether ultraviolet photofunctionalization could improve implant stability and support the clinical performance of early-loaded dental implants in the posterior mandible.

Tipo de estudo

Intervencional

Inscrição (Real)

10

Estágio

  • Não aplicável

Contactos e Locais

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Locais de estudo

      • Damascus, Síria
        • Department of Oral and Maxillofacial Surgery Faculty of Dentistry Damascus University Damascus, Syrian Arab Republic

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

Inclusion Criteria:

  1. Willingness to participate in the study and provision of written informed consent, with commitment to follow-up visits and study instructions.
  2. Good oral hygiene and satisfactory oral health status.
  3. Adults aged 18 years or older.
  4. Good general health with no systemic conditions contraindicating dental implant placement.
  5. Requirement for dental implant placement in the posterior mandible, with at least 6 months elapsed since tooth extraction.
  6. Adequate bone volume to allow implant placement without the need for bone grafting procedures.

Exclusion Criteria:

  1. Patients with parafunctional habits, including bruxism.
  2. Heavy smokers consuming more than 10 cigarettes per day.
  3. Patients receiving radiotherapy or chemotherapy.
  4. Long-term use of medications known to affect bone metabolism, such as corticosteroids.
  5. Pregnant or breastfeeding women.
  6. Insufficient interocclusal space for prosthetic rehabilitation.
  7. Patients with metabolic or bone disorders affecting bone quality or density, including hyperparathyroidism and osteoporosis.

Plano de estudo

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Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Quadruplicar

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Arm 1: Ultraviolet Photofunctionalized Dental Implants
This arm included dental implants that underwent ultraviolet photofunctionalization 24 hours before implant placement. Each participant received one ultraviolet photofunctionalized implant in a posterior mandibular edentulous site according to the randomized split-mouth design.
Dental implants assigned to the experimental arm underwent ultraviolet photofunctionalization 24 hours before implant placement by an independent investigator. The implants were subsequently placed in posterior mandibular edentulous sites and restored using an early loading protocol 4 weeks after surgery
Comparador Ativo: Conventional Dental Implants
This arm included dental implants placed without ultraviolet photofunctionalization. Each participant received one conventional implant in a comparable posterior mandibular edentulous site according to the randomized split-mouth design.
Dental implants assigned to the control arm were placed without ultraviolet photofunctionalization. The implants were inserted in comparable posterior mandibular edentulous sites and restored using the same early loading protocol 4 weeks after surgery

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Implant Stability Quotient (ISQ)
Prazo: At implant placement (baseline), 3 weeks after implant placement, and 4 weeks after implant placement.
Implant stability was measured using Resonance Frequency Analysis (RFA) with the Mega ISQ II device. Stability values were recorded as Implant Stability Quotient (ISQ) scores ranging from 1 to 100, with higher values indicating greater implant stability. Measurements were obtained immediately after implant placement, at 3 weeks, and at 4 weeks postoperatively before early loading.
At implant placement (baseline), 3 weeks after implant placement, and 4 weeks after implant placement.

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Peri-implant Marginal Bone Loss
Prazo: At implant placement (baseline) and one year after early loading.
Peri-implant marginal bone loss was evaluated using standardized periapical radiographs obtained immediately after implant placement and one year after early loading. Measurements were performed by assessing the vertical distance from the implant platform to the first bone-to-implant contact on both mesial and distal aspects of the implant. Bone level changes were calculated and recorded in millimeters (mm), with greater values indicating increased marginal bone loss
At implant placement (baseline) and one year after early loading.

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Investigadores

  • Cadeira de estudo: Issam Alkhouri, DDS, Phd, Faculty of Dentistry, Damascus University, Damascus, Syria
  • Investigador principal: Awab Al-Midani, Master's Degree Candidate, Faculty of Dentistry, Damascus University, Damascus, Syria

Publicações e links úteis

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Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

11 de dezembro de 2022

Conclusão Primária (Real)

8 de fevereiro de 2025

Conclusão do estudo (Real)

8 de março de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

3 de julho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

3 de julho de 2026

Primeira postagem (Real)

10 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

10 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

3 de julho de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • UDDS-2026-OralMaxillofacial-02

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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