Effect of Probe Material on Peri-implant Probing

Официальное название

Effect of Probe Material (Metallic vs. Plastic) on Peri-implant Probing: a Randomized Clinical Trial.

Обзор

Evaluate whether the type of probe (plastic vs. metallic) modifies the accuracy of peri-implant probing in single-unit implants, by comparing the probing depth recorded with the prosthesis in place versus without the prosthesis (ΔPD, mm). Secondarily, explore the influence of prosthetic design and implant position on probing values and on other clinical and radiographic parameters.

Подробное описание

Randomized clinical trial with two parallel groups. Eligible patients will be randomized (1:1 ratio) to one of two parallel treatment groups:

Group 1 (Metal probe): Peri-implant probing performed with a UNC-15 metallic periodontal probe (HuFriedy PCPUNC156).

Group 2 (Plastic probe): Peri-implant probing performed with a UNC-15 plastic periodontal probe (HuFriedy PCVO12PT).

Primary objective:

To evaluate whether the type of probe (plastic vs metallic) modifies the accuracy of peri-implant probing in single-unit implants, by comparing the probing depth recorded with the prosthesis in place versus without the prosthesis (ΔPS, mm).

Secondary objectives:

To explore the influence of prosthetic design (e.g., emergence profile, crown contour) and implant position on probing depth values and other clinical/radiographic parameters.

To evaluate patient-reported discomfort during peri-implant probing, recorded using a 100-mm visual analogue scale (VAS).

The study was designed in accordance with the international consensus on Implant Dentistry Core Outcome Set and Measurement (ID-COSM), published in the Journal of Clinical Periodontology in 2023. The protocol includes all applicable mandatory outcome domains recommended by this consensus for implant dentistry clinical trials.

Вмешательства

• Устройство Metallic UNC-15 periodontal probe
  Probing performed at six sites per implant with the prosthesis in place and after prosthesis removal, under standardized force (0.20 N).
• Устройство Plastic UNC-15 periodontal probe
  Probing performed at six sites per implant with the prosthesis in place and after prosthesis removal, under standardized force (0.20 N).

Первичные конечные точки

• Difference in probing depth with vs. without prosthesis (ΔPS, mm) [Срок оценки: Baseline (single clinical visit)]

Вторичные конечные точки (1)

• Patient Discomfort During Probing (VAS, 0-100 mm) [Срок оценки: Immediately after probing, at the study visit]

Критерии участия

Критерии включения

• Adults (≥18 years)
• Presence of at least one single-unit bone-level implant rehabilitated with a screw-retained prosthesis directly connected to the implant (no intermediate abutment)
• Implant in function for at least 1 year after prosthetic loading
• No pathological bone loss on periapical radiograph (distance from the most coronal rough surface of the implant to the bone crest < 3 mm)
• Ability to understand and sign informed consent
• Peri-implant health or mucositis, defined according to the 2017 World Workshop criteria:
• Health: no clinical signs of inflammation, lack of profuse (line or drop) bleeding on probing, no increase in probing depth compared to previous records, and no progressive bone loss beyond initial remodeling (<2 mm). In the absence of previous radiographs, radiographic bone level <3 mm without bleeding and/or suppuration on probing.
• Mucositis: presence of bleeding and/or suppuration on probing, no increase in probing depth compared to previous records, and no bone loss beyond initial remodeling (<2 mm). In the absence of previous radiographs, radiographic bone level <3 mm with bleeding and/or suppuration on probing.

Критерии исключения

• Cement-retained restorations or prostheses that cannot be removed
• Systemic antibiotic or anti-inflammatory treatment within the previous 3 months
• Pregnancy or lactation
• Peri-implant treatment within the previous 3 months
• Participation in another clinical trial within the last 30 days

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Диагностика

Центры проведения

Испания · 1 центр

• Hospital Odontològic Universitat de Barcelona — L'Hospitalet de Llobregat

Идентификаторы

NCT: NCT07304752 · 57/2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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