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AzTrials

Marginal Bone LossNCT06667531

Evaluation of Marginal Bone Loss (MBL) 12 Months Post-loading of Implants Supporting Individual Crowns, Based on the Height of the Intermediate Abutment and Its Placement Time. Immediate Abutments of 2 or 3 Mm Show the Lowest MBL, Whereas 1.5 Mm or Delayed Abutments Are Associated with Higher MBL.

A study testing Implant in people with Marginal Bone Loss, run by Quintas Hijós Clínica Dental at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Objectives:To determine which combination of abutment height and timing of placement is most effective in reducing marginal bone loss (MBL). Materials and Methods: 54 patients received at least one single screw-retained crown on an implant replacing a posterior tooth (60 implants). Read more about this study

Who is it for?
Ages 21 years and olderHealthy volunteers can take part
Conditions the study is for
Marginal Bone Loss
What is being tested?
Implant
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
1 siteSpain
Study dates
15 Jun 2022to 28 Jun 2024
Phase
Interventional
Are there results?
None posted in the registry

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 21 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Healthy adults.
  • Plaque and bleeding indices below 10%.
  • Absence of chronic periodontal diseases (periodontitis) or acute periodontal diseases (periodontal abscess).
  • Presence of intact alveolar walls.
  • Sufficient bone height and width.
  • Need for restoration of a tooth in the posterior maxillary or mandibular region (premolars and molars).
  • Incorporation into a periodontal maintenance program.

Who cannot join

  • History of systemic disease or radiotherapy contraindicating bone surgery.
  • Pregnant or breastfeeding women.
  • Smokers of more than 10 cigarettes per day.
  • Parafunctional habits.
  • Alcohol or drug abuse.
  • Narrow interproximal spaces (less than 9 mm).
  • Placement of implants flapless or post-extraction.
  • Insertion torque during implant placement below 35 Ncm.

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • University of Salamanca

    Salamanca, Salamanca, 37008

Other trials in Spain

About this study

Official title: Influence of Intermediate Abutment Height and Timing of Placement on Peri-implant Marginal Bone Loss in Single Implant-supported Crowns: a 12-month Follow-up Randomized Clinical Trial.

Objectives:To determine which combination of abutment height and timing of placement is most effective in reducing marginal bone loss (MBL).

Materials and Methods: 54 patients received at least one single screw-retained crown on an implant replacing a posterior tooth (60 implants). The implants were divided into six treatment groups based on the height (1.5 mm; 2 mm; 3 mm) and timing of placement (immediate: surgery 1; delayed: surgery 2) of the intermediate abutment: group 1 (height 3; surgery1), group 2 (height 2; surgery1), group 3 (height 1.5; surgery1), group 4 (height 3; surgery2), group 5 (height 2; surgery2), group 6 (height 1.5; surgery2). Mesial and distal linear radiographic measurements (from the implant shoulder to the bone crest) were performed at five follow-up times: implant surgery, crown placement (T1), and at 3 (T2), 6 (T3), and 12 months after loading (T4). Partial and total MBL were compared among the treatment groups.

Read the detailed description

All installed implants were BTI UnicCa® implants with a flat tetragonal internal connection (BTI Implant System, Vitoria, Spain) of universal (4.1 mm) or wide (5.5 mm) diameter. On all implants, anti-rotational intermediate abutments Ti Golden® UNIT (BTI Implant System, Vitoria, Spain) of universal (4.1 mm) or wide (5.5 mm) width and 1.5 mm, 2.0 mm, or 3.0 mm height were connected, either immediately during the installation surgery (protocol in one phase: one abutment - one time) or delayed during the second surgery procedure 8 weeks after installation (protocol in two phases: submerged implant). (Figure 1). For all patients, standardized digital intraoral radiographs with a silicone key and Rhin ring positioner were recorded during the surgical installation of the implant (baseline), during the placement of the prosthetic crown (8 weeks after surgery), and at 3, 6, and 12 months after prosthetic loading.

  • Surgical Procedures. Patients received a complete clinical (periodontal chart) and radiographic (intraoral radiographs, orthopantomography, and CBCT) examination. All surgical procedures were performed by the same surgeon (JQH) under local anesthesia (Artinibsa®; Inibsa Dental SLU, Barcelona, Spain). The implant size was selected based on digital planning with CBCT (Planmeca Romexis Software) according to the quantity and quality of bone. Prior to surgery, the thickness of the soft tissue (from the mucosal surface to the crestal bone) at the implant placement site was measured with a periodontal probe (15 mm, PCP UNC 15; HuFriedy). A conventional placement protocol was followed, with delayed installation of the implant in a fully healed socket (minimum 16 weeks of healing after tooth extraction). Osteotomy was performed without irrigation at low revolutions (100 rpm) following the defined protocol according to implant size and bone density. All implants were placed 1.5 mm subcrestally. All patients received pharmacological prescription with antibiotics (Amoxicillin 1 g every 12 hours for 7 days) or clindamycin in case of allergy, anti-inflammatory medication (Dexketoprofen 25 mg every 8 hours for 3 days), and probiotics (1 sachet per day for 1 week), in addition to postoperative care instructions: pressure with gauze for 5 minutes, application of ice for 10 minutes, soft and cold diet for the first 24 hours, and rinses with 0.12% chlorhexidine (Perioaid; Dentaid SL; Cerdanyola, Spain) twice a day for 7 days. Sutures were removed after 7 days.
  • Restorative Procedures. Eight weeks after the implant installation surgery, the platforms of the submerged implants were exposed and the intermediate abutment was connected with a torque of 35 Ncm. Ten weeks after surgery and after increasing the intermediate abutment torque to 35 Ncm on the non-submerged implants, the prosthetic phase began for all cases. All definitive implant-supported prostheses were unitary screw-retained metal-ceramic crowns. Records for the laboratory were obtained in all cases through digital intraoral scanning (iTero®; Align Technology Inc; San José; California, USA). The CAD design of the restorations was done using Exocad Software. The CAM fabrication of the restorations involved milling the metal framework and layering the ceramic covering on a printed model. The unitary crowns were screwed in 2 weeks after the scanning phase with a prosthetic screw torque of 20 Ncm (conventional loading for all cases: 12 weeks after implant placement surgery). The screw channels were sealed with Teflon and compact composite (GrandioSo; Voco GmbH; Cuxhaven, Germany). Occlusion was adjusted, and the adequacy of contact points and gingival sealing was checked.
  • Radiographic Evaluation. Standardized digital intraoral radiographs with a silicone key and Rhin ring positioner (Planmeca Prox + Planmeca Prosensor HD; Planmeca Oy; Helsinki, Finland) were obtained at implant placement (baseline), at definitive crown placement (T1), and at 3 months (T2), 6 months (T3), and 12 months (T4) after functional loading. For MBL measurement, the Planmeca Romexis dental imaging software platform was used. Linear measurements were taken in each intraoral radiograph from the most mesial and distal point of the implant shoulder to the crestal bone. The magnification of the radiographs was corrected based on the radiographic measurement of the height and width of each implant, from which each linear MBL measurement was calibrated and recalculated.
Being tested
Implant
Keywords
marginal bone loss, abutment height, abutment placement timing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ImplantProcedure or surgery

    Also called Oral Surgery

    Placement of an immediate intermediate abutment (in implant placement surgery). This abutment has a height of 3 mm.

  • ImplantProcedure or surgery

    Also called Oral Surgery

    Placement of an immediate intermediate abutment (in implant placement surgery). This abutment has a height of 2 mm.

  • ImplantProcedure or surgery

    Also called Oral Surgery

    Placement of an immediate intermediate abutment (in implant placement surgery). This abutment has a height of 1.5 mm.

  • ImplantProcedure or surgery

    Placement of a delayed intermediate abutment (in the second implant surgery). This abutment has a height of 3 mm.

  • ImplantProcedure or surgery

    Placement of a delayed intermediate abutment (in the second implant surgery). This abutment has a height of 2 mm.

  • ImplantProcedure or surgery

    Placement of a delayed intermediate abutment (in the second implant surgery). This abutment has a height of 1.5 mm.

Study groups in NCT06667531
Study groupRoleWhat they receive
Group 1 (height 3; surgery 1)Active comparatorPlacement of an immediate intermediate abutment (in implant placement surgery). This abutment has a height of 3 mm.
Receives: Procedure: Implant
Group 2 (height 2; surgery 1)Active comparatorPlacement of an immediate intermediate abutment (in implant placement surgery). This abutment has a height of 2 mm.
Receives: Procedure: Implant
Group 3 (height 1.5; surgery 1)Active comparatorPlacement of an immediate intermediate abutment (in implant placement surgery). This abutment has a height of 1.5 mm.
Receives: Procedure: Implant
Group 4 (height 3; surgery 2)Active comparatorPlacement of a delayed intermediate abutment (in the second implant surgery). This abutment has a height of 3 mm.
Receives: Procedure: Implant
Group 5 (height 2; surgery 2)Active comparatorPlacement of a delayed intermediate abutment (in the second implant surgery). This abutment has a height of 2 mm.
Receives: Procedure: Implant
Group 6 (height 1.5; surgery 2)Active comparatorPlacement of a delayed intermediate abutment (in the second implant surgery). This abutment has a height of 1.5 mm.
Receives: Procedure: Implant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Marginal bone loss (MBL) measured in mm (mm) 12 months after loading the implant.

    Cumulative MBL after 12 months of prosthetic loading measured in millimeters.

    Measured: 12 months

Secondary outcomes (1)
  1. Evolution over time of marginal bone loss (MBL) measured in millimeters (mm) at different stages.

    Partial MBL on the day of crown placement and 3, 6 and 12 months after loading, measured in millimeters.

    Measured: 0, 3, 6, 12 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Oct 2024
  2. Study start15 Jun 2022
  3. Primary completion1 May 2024
  4. Study completion28 Jun 2024

Resources

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
Model description
This controlled clinical trial aims to evaluate changes in peri-implant marginal bone levels during the first year of function around platform-switched implants placed 1.5 mm subcrestally and connected to intermediate abutments of heights 1.5, 2, and 3 mm, placed immediately at the time of the first surgery or delayed at the time of the second surgery. 54 patients received at least one single screw-retained crown on an implant replacing a posterior tooth (60 implants). The implants were divided into six treatment groups based on the height (1.5 mm; 2 mm; 3 mm) and timing of placement (immediate: surgery 1; delayed: surgery 2) of the intermediate abutment: group 1 (height 3; surgery 1), group 2 (height 2; surgery 1), group 3 (height 1.5; surgery 1), group 4 (height 3; surgery 2), group 5 (height 2; surgery 2), group 6 (height 1.5; surgery 2). Mesial and distal linear radiographic measurements (from the implant shoulder to the bone crest) were performed at five follow-up times: implant
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06667531
Sponsor's protocol ID
C.I. PI22/324
Status last verified
Oct 2024
First submitted
27 Oct 2024
Last updated
31 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Quintas-Hijos J, Perez-Pevida E. Influence of intermediate abutment height and timing of placement on marginal bone loss in single implant-supported crowns: a 12-month follow-up randomized clinical trial. Clin Oral Investig. 2025 May 8;29(6):291. doi: 10.1007/s00784-025-06364-8.

    PubMed 40335732

Questions about this trial

What is this clinical trial studying?

A study testing Implant in people with Marginal Bone Loss, run by Quintas Hijós Clínica Dental 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 7 inclusion and 8 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: finished, as of the sponsor's last update on 31 Oct 2024. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Marginal bone loss (MBL) measured in mm (mm) 12 months after loading the implant. (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06667531, which also lists 1 linked publication.

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 31 Oct 2024.

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