Impact of Abutment Screw Torque on Marginal Bone Loss

NCT ID: NCT07234552

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2027-04-30

Brief Summary

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.

Detailed Description

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.

The study protocol has been approved by the relevant ethics committee and will comply with all applicable clinical research regulations. All participants will provide written informed consent prior to enrollment.

Conditions

Soft Tissues According to the Abutment Torque; Microleakage Accordint to the Abutment Torque; PROMS According to the Abutment Torque; Marginal Bone Loss According to the Abutment Torque

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Transmucosal Abutment - 15 Ncm

Group Type: EXPERIMENTAL

Abutment torqued to 15 Ncm

Intervention Type: PROCEDURE

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.

Transmucosal Abutment - 30 Ncm

Group Type: EXPERIMENTAL

Pilar torqued to 30 Ncm

Intervention Type: PROCEDURE

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.

Submerged Healing Cap (No Transmucosal Connection)

Group Type: EXPERIMENTAL

2 mm healing cap

Intervention Type: PROCEDURE

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.

Interventions

Abutment torqued to 15 Ncm

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.

Intervention Type: PROCEDURE

Pilar torqued to 30 Ncm

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.

Intervention Type: PROCEDURE

2 mm healing cap

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• Loss to follow-up
• Incorrectly parallelized periapical radiographs

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Valencia

OTHER

Sponsor Role: lead

Responsible Party

Juan Carlos Bernabeu Mira

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paula Claver Baldovi

Role: PRINCIPAL_INVESTIGATOR

University of Valencia

Central Contacts

Juan Carlos Bernabeu Mira

Role: CONTACT

jcbernabeumira@gmail.com

+34 697 348 312

Other Identifiers

UV-INV_ETICA-3792382

Identifier Type: -

Identifier Source: org_study_id