Impact of Abutment Screw Torque on Marginal Bone Loss

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Valencia

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Loss to follow-up

Incorrectly parallelized periapical radiographs

Trial design

Design model

Parallel

Treatments tested in this trial

  • Abutment torqued to 15 Ncm

    Procedure/Surgery

    A dental implant surgery will be performed in which three implants will be placed. On one of them, a 2 mm slim abutment will be connected with a torque of 15 Ncm; on another, the same abutment will be connected with a torque of 30 Ncm; and on the third, a 2 mm healing cap will be placed and the implant will be left submerged for a subsequent second-stage surgery.

  • Pilar torqued to 30 Ncm

    Procedure/Surgery

    A dental implant surgery will be performed in which three implants will be placed. On one of them, a 2 mm slim abutment will be connected with a torque of 15 Ncm; on another, the same abutment will be connected with a torque of 30 Ncm; and on the third, a 2 mm healing cap will be placed and the implant will be left submerged for a subsequent second-stage surgery.

  • 2 mm healing cap

    Procedure/Surgery

    A dental implant surgery will be performed in which three implants will be placed. On one of them, a 2 mm slim abutment will be connected with a torque of 15 Ncm; on another, the same abutment will be connected with a torque of 30 Ncm; and on the third, a 2 mm healing cap will be placed and the implant will be left submerged for a subsequent second-stage surgery.

Treatment groups

30 Participants
are divided into 3 treatment groups
Group A: Transmucosal Abutment - 15 NcmExperimental treatment 1 intervention
Group B: Transmucosal Abutment - 30 NcmExperimental treatment 1 intervention
Group C: Submerged Healing Cap (No Transmucosal Connection)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Marginal bone loss (mm) assessed by standardized periapical radiographs

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.

Time frame
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)

Secondary outcomes

1

Postoperative pain intensity (VAS)

Pain intensity will be evaluated using a 10-point Visual Analog Scale (VAS), where 0 represents "no pain" and 10 represents "worst imaginable pain." Participants will complete the VAS at specified time points following surgery and prosthetic loading. Higher scores indicate more intense pain. This measure is part of the Patient-Reported Outcome Measures (PROMs) evaluated in this study.

Time frame
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
2

Postoperative swelling (VAS)

Facial swelling will be assessed using a 10-point Visual Analog Scale (VAS), where 0 represents "no swelling" and 10 represents "severe swelling." Assessments will be recorded at defined postoperative intervals. Higher scores indicate greater swelling. This measure is part of the Patient-Reported Outcome Measures (PROMs) evaluated in this study.

Time frame
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
3

Patient satisfaction with surgical and prosthetic phases (Likert-type questionnaire)

Satisfaction with the surgical and prosthetic phases will be assessed using Likert-type questionnaires addressing comfort, duration, and overall perception. Higher scores indicate greater satisfaction. This measure is part of the Patient-Reported Outcome Measures (PROMs) evaluated in this study.

Time frame
1 month post-op (surgical phase) and 3 months post-op (prosthetic loading). Unit of measure: Points on a likert-type scale
4

Oral health-related quality of life (Likert-type questionnaire)

Oral health-related quality of life-including speech, chewing, sleep, mouth opening, work, daily routine, and analgesic intake-will be assessed using Likert-type questionnaires. Higher scores indicate greater quality-of-life impact. This measure is part of the Patient-Reported Outcome Measures (PROMs) evaluated in this study.

Time frame
Baseline (before surgery); 1 month post-op; and 12 months post-loading. Unit of measure: Points on a likerts-type scale

Other outcomes

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