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Dental ImplantPhase 3NCT05711147

One-time Abutment Placement Versus 4 Times Abutment Removal Around Dental Implants

A Phase 3 study testing Abutment removal and Placement of definitive abutment in people with Dental Implant and Prosthetic Abutment, run by Universidad Complutense de Madrid at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Introduction: the repeated connection and disconnection of healing abutments during dental implants´ osseointegration has been associated with significant increased peri-implant bone loss, when compared with placing the final prosthetic abutment during implant placement surgery and non-removing it ever again. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Dental Implant, Prosthetic Abutment
What is being tested?
Abutment removal and Placement of definitive abutment
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
43 participants
Where
1 siteSpain
Study dates
1 Dec 2017to Dec 2023
Phase
Phase 3
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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • At least two adjacent missing teeth in the posterior maxilla or mandible (positions 4 to 7)
  • Willing to receive implant supported fixed partial dentures
  • There must be a natural tooth mesial to the most proximal implant site, however free end situations will be allowed for the distal implants
  • Healed sites (minimum 12 weeks post-extraction)
  • In the case of prior bone augmentation, a minimum of 6 months of healing is required
  • Simultaneous bone augmentation will be allowed only for close sinus lifting

Who cannot join

  • Systemic exclusion criteria:
  • Medical conditions requiring prolonged use of steroids and/or medications that can interfere with bone metabolism
  • History of leukocyte dysfunction and deficiencies
  • History of neoplastic disease requiring the use of radiation or chemotherapy
  • History of renal failure
  • Metabolic disorders such as osteoporosis
Show all 27Show fewer
  • History of uncontrolled endocrine disorders
  • Physical handicaps that would interfere with the ability to perform adequate oral hygiene
  • Alcoholism or drug abuse
  • History of immunodeficiency syndromes
  • Smokers of >10 cigarettes per day, cigar equivalents or tobacco chewers
  • Any other condition or circumstance that, in the opinion of the investigator, would prevent completion of the study participation or interfere with the analysis of the study results, such as history of non-compliance or unreliability
  • Local exclusion criteria:
  • Any kind of bone augmentation performed on the implant site, with a healing period of <6 months
  • Local inflammation (including untreated periodontitis)
  • Mucosal diseases such as erosive liquen planus
  • Less than 2mm of keratinized mucosa in the intended implant sites
  • History of local irradiation therapy
  • Presence of osseous lesions
  • History of implant failure
  • Post-extraction sites with <12 weeks of healing
  • Severe bruxism or clenching habits
  • Persistent intraoral infection
  • Exclusion criteria at surgery: in any of the following circumstances, the patient will not be randomized and will be excluded from the analysis
  • Lack of primary stability at surgery
  • Need for crestal augmentation procedures during implant surgery
  • Inability to place the implants according to the prosthetic requirements

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Dental School, University Complutense of Madrid

    Madrid, 28040

Other trials in Spain

About this study

Official title: One-time Abutment Placement Versus 4 Times Abutment Removal on Interproximal Bone Levels and Peri-implant Soft Tissues: a Prospective Randomized Clinical Trial

Introduction: the repeated connection and disconnection of healing abutments during dental implants´ osseointegration has been associated with significant increased peri-implant bone loss, when compared with placing the final prosthetic abutment during implant placement surgery and non-removing it ever again. Previous data from animal studies suggests that the higher the number of removals of the healing abutments, the greater the bone resorption around implants, however the evidence in humans is scarce and heterogeneous. Furthermore, this greater bone resorption has been claimed to be associated to the inflammatory status of the peri-implant soft tissues, which would be greater as a consequence of the repeated disruption of the soft-tissues attachment to the prosthetic abutment, and the hypothetical microbial contamination of the implant-abutment interphase, induced by the repeated manipulation of the prosthetic components.

Objective: to evaluate the changes in peri-implant crestal bone levels between two prosthetic protocols, the control being the conventional protocol where healing abutments are placed during surgery and removed four times before the delivery of the final abutment and prostheses, and the test protocol where definitive abutments are placed immediately after implant placement and are not removed ever again.

Material and methods: 80 platform switched implants will be placed in the posterior maxilla or mandible of 40 partial edentulous patients. Immediately after implant placement, patients will be randomized to receive the definitive abutment at the moment of implant placement (one abutment-one time protocol), or 12 weeks later, after removing the healing abutment four times during the confection of the final prostheses, following the conventional protocol for implant supported restorations. The day of prostheses delivery, a mucosal biopsy from the implant surrounding tissues will be taken for histomorphometric and immunohistochemical analyses of the inflammatory response of the peri-implant soft tissues. Radiographic assessment of vertical bone level changes (primary outcome), clinical status of peri-implant tissues, changes in soft tissues margin, patient related outcomes and adverse events will be assessed at 6, 12, 24 and 36 months after loading.

Being tested
Abutment removal, Placement of definitive abutment

What participants receive

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

  • Abutment removalProcedure or surgery

    4 times healing abutment removal during prosthesis making (impressions, metal try-in, ceramic try-in, prosthesis loading)

  • Placement of definitive abutmentProcedure or surgery

    Placement of the final prosthetic abutment at the moment of implantation

Study groups in NCT05711147
Study groupRoleWhat they receive
Definitive abutmentExperimentalDefinitive prosthetic abutment placed at the moment of implant placement
Receives: Procedure: Placement of definitive abutment
Healing abutmentActive comparatorConventional healing abutment placed at the moment of implant placement and removed 4 times during prosthesis making
Receives: Procedure: Abutment removal

What is being measured

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

  1. Changes in interproximal bone levels

    Changes at the mesial and distal crestal bone levels measured in periapical digital radiographs at the mesial and distal implant aspects

    Measured: Implantation, prosthesis loading, 6 months, 12 months, 24 months, 36 months

Secondary outcomes (12)

  1. Mobility

    Implant and/or prostheses mobility

    Measured: Prosthesis loading, 6 months, 12 months, 24 months, 36 months

  2. Keratinized peri-implant mucosa

    Presence or absence of keratinized peri-implant mucosa in the mid-buccal and mid-lingual aspects

    Measured: Prosthesis loading, 6 months, 12 months, 24 months, 36 months

  3. Modified plaque index

    Modified plaque index (Mombelli et al. 1987) at six sites per implant

    Measured: Prosthesis loading, 6 months, 12 months, 24 months, 36 months

  4. Sulcus bleeding index

    Sulcus bleeding index (Mombelli et al. 1987) at six sites per implant

    Measured: Prosthesis loading, 6 months, 12 months, 24 months, 36 months

  5. Probing depth

    Probing depth (Mombelli et al. 1987) at six sites per implant

    Measured: Prosthesis loading, 6 months, 12 months, 24 months, 36 months

  6. Clinical crown length of the adjacent tooth

    CLT: distance in mm from the highest line of gingival/mucosal curvature of the crown to the occlusal aspect of the tooth

    Measured: Prosthesis loading, 6 months, 12 months, 24 months, 36 months

  7. Clinical crown length of the implant supported crown

    CLI: distance in mm from the highest line of mucosal curvature of the crown to the occlusal aspect of the implant prostheses

    Measured: Prosthesis loading, 6 months, 12 months, 24 months, 36 months

  8. Papilla index

    IP: distance in mm from the top of the mesial and distal papillae of each implant to the most coronal portion of the contact point or the occlusal surface (Grunder 2000)

    Measured: Prosthesis loading, 6 months, 12 months, 24 months, 36 months

  9. Patient-reported outcomes

    5-items questionnaire (comfort, appearance, masticatory function, taste and overall satisfaction) rated according to the following scale: very unsatisfied, unsatisfied, fair, satisfied, and very satisfied

    Measured: Prosthesis loading, 6 months, 12 months, 24 months, 36 months

  10. Adverse events

    Occurrence and nature of adverse events, either "implant or prostheses associated" (device related adverse events and other tissue complications), or "non-implant associated" (death, serious illness or any condition requiring hospitalization for more than 1 day).

    Measured: Prosthesis loading, 6 months, 12 months, 24 months, 36 months

  11. Hystomorphometric analysis of soft tissue biopsy samples

    Total areas of the sample, the epithelium, the connective tissue, the inflammatory infiltrate and cell density in an interest area into the inflammatory infiltrate

    Measured: Prosthesis loading

  12. Immunohistochemical analysis of the histologic sections

    Nature and extension of the inflammatory infiltrate in the connective tissue: high positive (HP), positive (P), low positive (LP) or negative (N) staining

    Measured: Prosthesis loading

Timeline

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

  1. First posted2 Feb 2023
  2. Study start1 Dec 2017
  3. Primary completionDec 2023 (estimated)
  4. Study completionDec 2023 (estimated)

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05711147
Sponsor's protocol ID
17/291-R_X
Status last verified
Feb 2023
First submitted
24 Jan 2023
Last updated
21 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Abutment removal and Placement of definitive abutment in people with Dental Implant and Prosthetic Abutment, run by Universidad Complutense de Madrid 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 6 inclusion and 27 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: status not confirmed, as of the sponsor's last update on 21 Feb 2023. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

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?

Changes in interproximal bone levels (time frame: Implantation, prosthesis loading, 6 months, 12 months, 24 months, 36 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 NCT05711147.

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 21 Feb 2023.

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