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Efficacy of Implant Surface Characteristics in Patients With History of Periodontitis

Primary Purpose

Marginal Bone Loss

Status

Completed

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Implant placement surgery

About this trial

This is an interventional treatment trial for Marginal Bone Loss focused on measuring Implant surface, hybrid, Peri-implantitis, Periodontitis, Marginal bone loss

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

•> 20 years of age

Presence of ≥1 adjacent missing teeth, in either maxilla or mandible (up to three missing units).
A natural tooth had to be present mesially to the most proximal implant site, although free end situations were allowed, and opposing dentition had to be natural teeth or implant supported fixed restorations.
History of treated and controlled periodontitis.
Presence of adequate bone volume to achieve primary implant stability without concomitant regeneration

Exclusion Criteria:

Diseases affecting bone metabolism or wound healing (e.g.)
History of radiation therapy, leukocyte dysfunction, or any other immunodeficiency
Drug abuse
Intrasurgical exclusion criteria, such as the lack of primary stability, the need of bone augmentation or the impossibility of placing the implant based on prosthetic requirements. �

Sites / Locations

Facultad de odontología, Complutense University of Madrid

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Test group

Control group

Arm Description

Hybrid surface dental implant

moderately rough surface implant

Outcomes

Primary Outcome Measures

Radiographic marginal bone levels Change

Radiographic marginal bone levels (bone loss) are defined as the distance between the bone crest and the implant shoulder at mesial and distal sites. For standardization of periapical radiographs the same film holder-beam aiming device will be applied (Rinn System) and silicone custom-made bite blocks will be used to improve reproducible repositioning. All digital radiographs will be evaluated by one calibrated and trained researcher (BS) using a software (AutoCAD® Autodesk ®, California, USA) that allows to calibrate the distances using the known implant length.

Secondary Outcome Measures

Clinical periodontal outcome measurements change

Clinical measurements will be performed at six sites per implant of i) probing depth (PD), ii) marginal mucosa recession assessed as length of the implant crown (CLI; distance from the mucosal margin to the oclusal surface at the mid buccal point), iii) bleeding on probing (BoP) and iv) plaque scores (PI). Finally, peri-implant mucositis, defined as the presence of profuse BoP.

Microbiologic outcome measurements change

Paper points will be inserted to the depth of the peri-implant pocket and kept in place for 15 sec. The points will be transferred into a screw-capped vial, containing 1.5 ml of reduced transport fluid, (RTF) and maintained at -20ºC. Microbiological analysis by means of anaerobic culture will be performed for the determination of counts, proportion and frequency of detection of Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Tannerella forsythia, Prevotella intermedia and Fusobacterium nucleatum.�

Patient reported outcome measures (PROM's)change

PROM´s will be assessed by means of a questionnaire comprising 4 items: comfort, appearance, masticatory function and overall satisfaction. Patients will be asked to rate these four aspects according to the following scale: very unsatisfied, unsatisfied, fair, satisfied and very satisfied.

Full Information

NCT ID

NCT05010382

First Posted

August 3, 2021

Last Updated

August 14, 2021

Sponsor

Universidad Complutense de Madrid

Collaborators

Ti Care S.L

1. Study Identification

Unique Protocol Identification Number

NCT05010382

Brief Title

Efficacy of Implant Surface Characteristics in Patients With History of Periodontitis

Official Title

Efficacy of Two Dental Implants With Different Surface Characteristics in Patients With History of Periodontitis. A Randomized Controlled Clinical Trial.

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Completed

Study Start Date

March 13, 2018 (Actual)

Primary Completion Date

July 25, 2021 (Actual)

Study Completion Date

July 25, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universidad Complutense de Madrid

Collaborators

Ti Care S.L

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The aim of the study is to evaluate in patients with history of periodontitis the clinical, microbiological and radiological outcomes of implants with a modified implant design consisting on a machined surface in the coronal third of the implant. In this 12-month, parallel-arm, randomized controlled trial, patients with history of treated periodontitis and in need of dental implants for single-unit or short edentulous spaces (i.e. two implants) will be randomly assigned to a test group (implants with a hybrid surface, presenting a machined coronal third; HS) or a control group (conventional moderately rough implants; RS). Implants will be restored 3 months later with fixed implant supported reconstructions. Radiological, clinical, microbiological and patient-related outcome measures (PROMs) will be assessed 3, 6 and 12 months after the prosthetic installation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Marginal Bone Loss

Keywords

Implant surface, hybrid, Peri-implantitis, Periodontitis, Marginal bone loss

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Patients will recieve an implant with either hybrid surface (test group) or moderately rough surface (control implants

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Test group

Arm Type

Experimental

Arm Description

Hybrid surface dental implant

Arm Title

Control group

Arm Type

Experimental

Arm Description

moderately rough surface implant

Intervention Type

Procedure

Intervention Name(s)

Implant placement surgery

Intervention Description

Under local anaesthesia, full-thickness mucoperiosteal flaps were elevated, the alveolar ridge measured, and a proper implant dimension (3.75 mm and 4.25 mm diameter; 8 mm, 10 mm and 11.5 mm length) and position selected. After site preparation, each patient was randomly allocated to the test or the control group. Patients in the test group received a modified implant design with the coronal third presenting a machined surface (hybrid surface (HS) group), while in the control group the same implant design with a titanium rough surface up to the implant shoulder was used (rough surface (RS) group). Implants were placed 1 mm sub-crestally. In the case of dehiscence or fenestrations around the implant, the patient was excluded from the study. Once inserted, healing abutments (ranging between 3 -5 mm) were placed, and flaps sutured around the abutments to allow for a transmucosal healing.

Primary Outcome Measure Information:

Title

Radiographic marginal bone levels Change

Description

Time Frame

Change between baseline and 12 months

Secondary Outcome Measure Information:

Title

Clinical periodontal outcome measurements change

Description

Time Frame

Change between baseline and 12 months

Title

Microbiologic outcome measurements change

Description

Time Frame

Change between baseline and 12 months

Title

Patient reported outcome measures (PROM's)change

Description

Time Frame

Change between baseline and 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: •> 20 years of age Presence of ≥1 adjacent missing teeth, in either maxilla or mandible (up to three missing units). A natural tooth had to be present mesially to the most proximal implant site, although free end situations were allowed, and opposing dentition had to be natural teeth or implant supported fixed restorations. History of treated and controlled periodontitis. Presence of adequate bone volume to achieve primary implant stability without concomitant regeneration Exclusion Criteria: Diseases affecting bone metabolism or wound healing (e.g.) History of radiation therapy, leukocyte dysfunction, or any other immunodeficiency Drug abuse Intrasurgical exclusion criteria, such as the lack of primary stability, the need of bone augmentation or the impossibility of placing the implant based on prosthetic requirements. �

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mariano Sanz Alonso, Chair

Organizational Affiliation

Universidad Complutense de Madrid

Official's Role

Study Chair

Facility Information:

Facility Name

Facultad de odontología, Complutense University of Madrid

City

Madrid

ZIP/Postal Code

28040

Country

Spain

12. IPD Sharing Statement

Plan to Share IPD

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Efficacy of Implant Surface Characteristics in Patients With History of Periodontitis

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