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Early Loading of UV-Functionalized Dental Implants

3 luglio 2026 aggiornato da: 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.

Panoramica dello studio

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Effettivo)

10

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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
Comparatore attivo: 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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Implant Stability Quotient (ISQ)
Lasso di tempo: 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.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Peri-implant Marginal Bone Loss
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Cattedra di studio: Issam Alkhouri, DDS, Phd, Faculty of Dentistry, Damascus University, Damascus, Syria
  • Investigatore principale: Awab Al-Midani, Master's Degree Candidate, Faculty of Dentistry, Damascus University, Damascus, Syria

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

11 dicembre 2022

Completamento primario (Effettivo)

8 febbraio 2025

Completamento dello studio (Effettivo)

8 marzo 2026

Date di iscrizione allo studio

Primo inviato

3 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

3 luglio 2026

Primo Inserito (Effettivo)

10 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

10 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

3 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • UDDS-2026-OralMaxillofacial-02

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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