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Effect of Bone-related and Soft-tissue-related Variables on the Marginal Bone Loss of Platform-matched and Platform Switched Dental Implants

Primary Purpose

Dental Implant, Soft Tissue, Partial-edentulism

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Switched Prosthetic Profile
Matched Prosthetic Profile
Sponsored by
University of Salamanca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Implant focused on measuring dental implant, marginal bone loss, peri-implant soft tissue, ISQ

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Patients of legal age (>18 years). With rehabilitation needs with 1 maxillary or mandibular implant in mature bone (more than 4 months after tooth extraction) in the posterior sector (premolars and molars). With good hygiene (plaque and gingival index ≤ 25%). Exclusion Criteria: Medical conditions that contraindicated implant surgery. Patients with immunological alterations, pregnant and lactating. Heavy smokers > 20 cigarettes/day, Requiring bone augmentations or of soft tissues. Patients whose anatomy prevented the correct three-dimensional placement of the implant to perform prosthetically guided screw-retained restorations.

Sites / Locations

  • Javier MonteroRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Swithed-platform

Matched-platform

Arm Description

In this group the implants will be rehabilitated with a narrower emergence profile for the prosthetic rehabilitation.

This the conventional approach in wich the prosthetic rehabilitation is matched with the implant-platform dimensions

Outcomes

Primary Outcome Measures

Change in the Peri-implant Marginal Bone level
The implant-bone level is assesssed radiographicly
Change in the Implant stablity quotient
The ISQ is assesssed by Osstell
Change in the Gingival Thickness
The gingival thickness will be assessed by measuring the keratinized region around implants with a periodontal probe and a thickness caliper

Secondary Outcome Measures

Full Information

First Posted
November 29, 2022
Last Updated
April 24, 2023
Sponsor
University of Salamanca
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1. Study Identification

Unique Protocol Identification Number
NCT05670340
Brief Title
Effect of Bone-related and Soft-tissue-related Variables on the Marginal Bone Loss of Platform-matched and Platform Switched Dental Implants
Official Title
Effect of Bone-related and Soft-tissue-related Variables on the Marginal Bone Loss of Platform-matched and Platform Switched Dental Implants
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 22, 2020 (Actual)
Primary Completion Date
May 20, 2023 (Anticipated)
Study Completion Date
July 12, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Salamanca

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Implant, Soft Tissue, Partial-edentulism, Bone Loss
Keywords
dental implant, marginal bone loss, peri-implant soft tissue, ISQ

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
only the care provider knows the group asignement
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Swithed-platform
Arm Type
Experimental
Arm Description
In this group the implants will be rehabilitated with a narrower emergence profile for the prosthetic rehabilitation.
Arm Title
Matched-platform
Arm Type
Active Comparator
Arm Description
This the conventional approach in wich the prosthetic rehabilitation is matched with the implant-platform dimensions
Intervention Type
Device
Intervention Name(s)
Switched Prosthetic Profile
Intervention Description
The implant will be rehabilitated with a switched emergence profile
Intervention Type
Device
Intervention Name(s)
Matched Prosthetic Profile
Intervention Description
The implant will be rehabilitated with a matched emergence profile
Primary Outcome Measure Information:
Title
Change in the Peri-implant Marginal Bone level
Description
The implant-bone level is assesssed radiographicly
Time Frame
At baseline (reference), in comparison with 3, 6 and 12 months
Title
Change in the Implant stablity quotient
Description
The ISQ is assesssed by Osstell
Time Frame
At baseline (reference), and in comparison with the 3 months follow-up
Title
Change in the Gingival Thickness
Description
The gingival thickness will be assessed by measuring the keratinized region around implants with a periodontal probe and a thickness caliper
Time Frame
At baseline (reference) and in comparison with the 3, 6 and 12 months follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients of legal age (>18 years). With rehabilitation needs with 1 maxillary or mandibular implant in mature bone (more than 4 months after tooth extraction) in the posterior sector (premolars and molars). With good hygiene (plaque and gingival index ≤ 25%). Exclusion Criteria: Medical conditions that contraindicated implant surgery. Patients with immunological alterations, pregnant and lactating. Heavy smokers > 20 cigarettes/day, Requiring bone augmentations or of soft tissues. Patients whose anatomy prevented the correct three-dimensional placement of the implant to perform prosthetically guided screw-retained restorations.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Javier Montero, Professor
Phone
619429971
Email
javimont@usal.es
Facility Information:
Facility Name
Javier Montero
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
JAVIER MONTERO, FULL PROFESSOR
Phone
34 923 294 500
Ext
1996
Email
javimont@usal.es
First Name & Middle Initial & Last Name & Degree
NORBERTO QUISPE LÓPEZ, ASSOCIATE PROFESSOR

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of Bone-related and Soft-tissue-related Variables on the Marginal Bone Loss of Platform-matched and Platform Switched Dental Implants

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