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临床试验/NCT07234552
NCT07234552招募中不适用

Impact of Abutment Screw Torque Values on Marginal Bone Loss and Peri-Implant Parameters: A Three-Arm Randomized Clinical Trial

University of Valencia1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年1月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
1
主要终点
Marginal bone loss (mm) assessed by standardized periapical radiographs

研究概览

简要总结

The objective of this clinical trial is to evaluate the impact of different torque values applied during transmucosal abutment placement in dental implants on marginal bone loss and peri-implant parameters, including the patient's perception of the treatment.

The main questions the study aims to answer are:

  1. Is there any difference in marginal bone loss between abutments torqued at 15 Ncm, 30 Ncm, and submerged implants without immediate transmucosal connection?
  2. Are there differences in microleakage between the different torque levels?
  3. How do these torque values affect peri-implant soft tissues and patient satisfaction?
  4. Does the applied torque influence the patient's quality of life after the prosthetic phase?

Each participant will receive three dental implants during the same surgical procedure. One of the following approaches will be applied to each implant:

  1. A transmucosal abutment torqued to 15 Ncm
  2. A transmucosal abutment torqued to 30 Ncm
  3. A healing cap without transmucosal connection (submerged implant)

After implant placement, clinical and radiographic assessments will be performed to measure marginal bone loss and peri-implant parameters.

详细描述

This study aims to analyze how different torque levels applied during transmucosal abutment placement on dental implants influence peri-implant tissue health and other relevant clinical parameters. A randomized clinical trial will be conducted in which each participant will receive three dental implants. Each implant will be assigned to one of the following conditions: an abutment torqued to 15 Ncm, an abutment torqued to 30 Ncm, and a submerged implant with a healing cap, without immediate transmucosal connection.

This intra-individual design enables direct comparison of outcomes while minimizing inter-individual variability that could affect the results.

Throughout the treatment process, various data will be collected. During surgery, patient-reported comfort levels will be recorded. Following prosthesis placement, standard clinical measurements will be performed, including peri-implant probing, bleeding on probing, inflammation, and radiographic evaluation of marginal bone loss.

Additionally, patient-reported outcomes during the first week after the initiation of the prosthetic phase will be documented, including pain levels, inflammation, and analgesic use. Overall satisfaction and the impact of treatment on quality of life will also be assessed using a Likert-type scale, focusing on functions such as chewing, speech, sleep, and daily activities.

The goal of this study is to determine whether the torque applied during abutment connection has a clinically relevant effect on both peri-implant tissue response and patient perception of the treatment. The findings may contribute to improved clinical guidelines in implant dentistry and enhance long-term treatment outcomes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Posterior edentulism
  • Completion of craniofacial growth
  • Full-mouth plaque index and bleeding index < 25%
  • Sufficient bone height and width for implant placement without the need for bone regeneration procedures
  • Presence of at least 2 mm of keratinized mucosa around the dental implant
  • Stable occlusion and healthy periodontium
  • Absence of medical conditions that contraindicate implant surgery, such as heavy smoking (<10 cigarettes per day), severe bruxism, pregnancy or breastfeeding, bisphosphonate therapy, and patients undergoing chemotherapy or radiotherapy in the head and/or neck area
  • Uncooperative patients

排除标准

  • Loss to follow-up
  • Incorrectly parallelized periapical radiographs

研究组 & 干预措施

Transmucosal Abutment - 15 Ncm

Experimental

干预措施: Abutment torqued to 15 Ncm (Procedure)

Transmucosal Abutment - 30 Ncm

Experimental

干预措施: Pilar torqued to 30 Ncm (Procedure)

Submerged Healing Cap (No Transmucosal Connection)

Experimental

干预措施: 2 mm healing cap (Procedure)

结局指标

主要结局

Marginal bone loss (mm) assessed by standardized periapical radiographs

时间窗: Day 0 (surgery); 1 month post-op; 3 months post-op (prosthetic loading); and 1, 3, 6, and 12 months post-loading. Unit of measure: Milimeters (mm)

Marginal bone loss will be measured on standardized digital periapical radiographs taken using the parallel technique. A calibrated digital tool will be used to determine the vertical distance from the implant-abutment junction to the most coronal bone-to-implant contact on the mesial and distal sides. Measurements will be collected at seven time points for each participant.

次要结局

  • Postoperative pain intensity (VAS)(Immediately after surgery; 1, 3, and 7 days post-surgery; and 1, 3, and 7 days post-loading. Unit of measure: Points on a 0-10 scale)
  • Postoperative swelling (VAS)(Immediately after surgery; 1, 3, and 7 days post-surgery; and 1, 3, and 7 days post-loading. Unit of measure: Points on a 0-10 scale)
  • Patient satisfaction with surgical and prosthetic phases (Likert-type questionnaire)(1 month post-op (surgical phase) and 3 months post-op (prosthetic loading). Unit of measure: Points on a likert-type scale)
  • Oral health-related quality of life (Likert-type questionnaire)(Baseline (before surgery); 1 month post-op; and 12 months post-loading. Unit of measure: Points on a likerts-type scale)
  • Peri-implant probing depth (mm)(3 months post-op (prosthetic loading); and 1, 3, 6, and 12 months post-loading. Unit of measure: Milimeters (mm))
  • Bleeding on probing (presence/absence)(3 months post-op (prosthetic loading); and 1, 3, 6, and 12 months post-loading. Unit of measure: Percentage of implant sites with bleeding (%))
  • Mucosal inflammation (visual assessment)(3 months post-op (prosthetic loading); and 1, 3, 6, and 12 months post-loading. Unit of measure: Presence or absence of inflammation (binary))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Juan Carlos Bernabeu Mira

Professor

University of Valencia

研究点 (1)

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