Soft Tissues According to the Abutment TorqueNCT07234552
Impact of Abutment Screw Torque on Marginal Bone Loss
A study testing Abutment torqued to 15 Ncm, Pilar torqued to 30 Ncm and 2 mm healing cap in people with Soft Tissues According to the Abutment Torque and Microleakage Accordint to the Abutment Torque, run by University of Valencia at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Soft Tissues According to the Abutment Torque, Microleakage Accordint to the Abutment Torque, PROMS According to the Abutment Torque
- What is being tested?
- Abutment torqued to 15 Ncm, Pilar torqued to 30 Ncm and 2 mm healing cap
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2026to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Loss to follow-up
- Incorrectly parallelized periapical radiographs
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Clinica Odontologica UV
Valencia, Valencia, 46010
About this study
Official title: Impact of Abutment Screw Torque Values on Marginal Bone Loss and Peri-Implant Parameters: A Three-Arm Randomized Clinical 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:
Read more
- Is there any difference in marginal bone loss between abutments torqued at 15 Ncm, 30 Ncm, and submerged implants without immediate transmucosal connection?
- Are there differences in microleakage between the different torque levels?
- How do these torque values affect peri-implant soft tissues and patient satisfaction?
- 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:
- A transmucosal abutment torqued to 15 Ncm
- A transmucosal abutment torqued to 30 Ncm
- 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.
Read the 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
- Being tested
- Abutment torqued to 15 Ncm, Pilar torqued to 30 Ncm, 2 mm healing cap
- Keywords
- Dental implant, Torque, Marginal bone loss, Microleakage, Abutment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abutment torqued to 15 NcmProcedure or 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 NcmProcedure or 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 capProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| Transmucosal Abutment - 15 Ncm | Experimental | Not described Receives: Procedure: Abutment torqued to 15 Ncm |
| Transmucosal Abutment - 30 Ncm | Experimental | Not described Receives: Procedure: Pilar torqued to 30 Ncm |
| Submerged Healing Cap (No Transmucosal Connection) | Experimental | Not described Receives: Procedure: 2 mm healing cap |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (7)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
Probing depth will be measured at four sites per implant (mesial, distal, buccal, lingual) using a calibrated periodontal probe. The mean value per implant will be recorded. Lower values indicate healthier peri-implant tissues.
Measured: 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)
Bleeding on probing will be assessed at four sites per implant (mesial, distal, buccal, lingual). The presence or absence of bleeding within 30 seconds after gentle probing will be recorded. The percentage of sites showing bleeding will be calculated for each implant. Lower percentages indicate healthier peri-implant tissues.
Measured: 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)
Mucosal inflammation around each implant will be evaluated by visual inspection for redness, swelling, and other clinical signs. Each implant site will be classified as showing inflammation or not. Lower prevalence of inflammation indicates healthier peri-implant tissues.
Measured: 3 months post-op (prosthetic loading); and 1, 3, 6, and 12 months post-loading. Unit of measure: Presence or absence of inflammation (binary)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start1 Jan 2026
- Primary completionMar 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissues According to the Abutment TorqueStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan Carlos Bernabeu Mira, University of Valencia
- Investigators
- Paula Claver Baldovi, Principal investigator, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07234552
- Sponsor's protocol ID
- UV-INV_ETICA-3792382
- Status last verified
- Jun 2026
- First submitted
- 6 Jun 2025
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The plan to share individual participant data (IPD) has not yet been determined. A final decision will depend on data quality, ethical considerations, and publication status.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Abutment Screw Torque Values on Marginal Bone Loss and Peri-Implant Parameters: A Three-Arm Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07234552
- Acronym / sponsor ID
- UV-INV_ETICA-3792382
- 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
- Keywords
- Dental implant, Torque, Marginal bone loss, Microleakage, Abutment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 18 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Is there any difference in marginal bone loss between abutments torqued at 15 Ncm, 30 Ncm, and submerged implants without immediate transmucosal connection?
- Are there differences in microleakage between the different torque levels?
- How do these torque values affect peri-implant soft tissues and patient satisfaction?
- 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:
- A transmucosal abutment torqued to 15 Ncm
- A transmucosal abutment torqued to 30 Ncm
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Transmucosal Abutment - 15 Ncm | Experimental | Procedure: Abutment torqued to 15 Ncm |
| Transmucosal Abutment - 30 Ncm | Experimental | Procedure: Pilar torqued to 30 Ncm |
| Submerged Healing Cap (No Transmucosal Connection) | Experimental | Procedure: 2 mm healing cap |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (2 listed)
- Loss to follow-up
- Incorrectly parallelized periapical radiographs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abutment torqued to 15 NcmA 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. | Procedure or surgery | Transmucosal Abutment - 15 Ncm |
| Pilar torqued to 30 NcmA 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. | Procedure or surgery | Transmucosal Abutment - 30 Ncm |
| 2 mm healing capA 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. | Procedure or surgery | Submerged Healing Cap (No Transmucosal Connection) |
Primary outcome
Marginal bone loss (mm) assessed by standardized periapical radiographs
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)
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.
7 secondary outcomes
Postoperative pain intensity (VAS)
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
Postoperative swelling (VAS)
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
Patient satisfaction with surgical and prosthetic phases (Likert-type questionnaire)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 3 months post-op (prosthetic loading); and 1, 3, 6, and 12 months post-loading. Unit of measure: Presence or absence of inflammation (binary)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: Undecided. The plan to share individual participant data (IPD) has not yet been determined. A final decision will depend on data quality, ethical considerations, and publication status.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Paula Claver Baldovi principal investigator
University of Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abutment torqued to 15 Ncm, Pilar torqued to 30 Ncm and 2 mm healing cap in people with Soft Tissues According to the Abutment Torque and Microleakage Accordint to the Abutment Torque, run by University of Valencia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Juan Carlos Bernabeu Mira (+34 697 348 312, jcbernabeumira@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Marginal bone loss (mm) assessed by standardized periapical radiographs (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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.