Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05670340 |
| Other study ID # |
Usal_2020_433 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 22, 2020 |
| Est. completion date |
February 1, 2024 |
Study information
| Verified date |
May 2024 |
| Source |
University of Salamanca |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
In this clinical trial the effect of the implant-abutment morphology (platform-switched vs
platform matched) will be assessed in both soft tissue (soft tissue thickness) and hard
tissue (marginal bone loss) outcomes. Several clinical predictors (initial implant position
level, gingival biotype, abutment height and prosthetic emergence profile) will also be taken
into account as modulating factors of the clinical outcome.
Description:
This prospective clinical trial is conducted at the Dental Clinic of the Faculty of Medicine
of the University of Salamanca. The protocol was developed in accordance with the 1975
Declaration of Helsinki, and later approved by the Bioethics Committee of the University of
Salamanca with the number (Ref:473/2020)
Before initiating any procedure, each patient received information about the study design and
signed an informed consent. The subjects are recruited consecutively following the admission
protocols of the Dental Clinic of the Faculty of Medicine of the University of Salamanca,
Salamanca, Spain. The inclusion criteria are:
(1) Patients of legal age (>18 years); (2) in need of at least one maxillary or mandibular
dental implant to be inserted in mature bone (more than 4 months after tooth extraction) in
the posterior area (premolars and molars); (3) with good oral hygiene (plaque and gingival
index ≤ 25%). The exclusion criteria included clinical conditions that contraindicated
implant surgery, (1) patients with immunological alterations, pregnant and lactating, (2)
heavy smokers > 20 cigarettes/day, (3) with the need for bone or soft tissue augmentations,
(4) patients whose anatomy prevented the correct three-dimensional placement of the implant
to perform prosthetically guided screwed restorations.
All implants were placed by an experienced implantologist following standard procedures and
the manufacturer's recommendations. All implants were connected to a transmucosal abutment to
heal in one-stage approach. Several variables were collected in this surgical phase (bone
quality, implant stability, implant-bone level, mucosal thickness, keratinized mucosa width
...)
After 3 to 4 months of implant healing all the clinical parameters were reevaluated and the
final impression will be used for the manufacturing of a porcelain-fused to metal screwed
crowns.
Two types of data will be analyzed: Cross-sectional and longitudinal data. On the one hand,
cross-sectional data included sociodemographic (sex and age), behavioral (smoking, oral
hygiene..) clinical (antagonist, adjacent dentition, arch location, implant diameter and
length, insertion torque values, bone density, implant-level...) and prosthetics (abutment
and prosthetic profiles, interocclusal prosthetic space, cantilever lengths...).
On the other hand, the longitudinal variables were classified into 2 types, related to the
gingival tissues and related to the surrounding bone. Regarding the gingival tissues these
were the longitudinal variables assessed in different follow-up observations (at 3, 6 and 12
months): plaque and gingival index, keratinized mucosa width. Regarding the bone-related
variables the implant stability by ISQ as well as the marginal bone position were also
measured at 3, 6 and 12 months.
