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Evaluation of Soft Tissue Response to Titanium Healing Abutments Treated by Erbium: YAG Laser or Plasma Spray

Primary Purpose

Peri-implant Mucositis

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Er: YAG laser
plasma spray
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peri-implant Mucositis focused on measuring healing abutment, plasma spray, Er: YAG laser

Eligibility Criteria

20 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male and female patients with age range from 20 to 45 years old. Patients need placement of fixed implant-supported prosthesis in maxillary arch. Patients who are medically free from any systemic diseases as evidenced by the health questionnaire, using modified Cornell medical index (Pendleton et al., 2004). patients with good oral hygiene (Plaque Index and bleeding on probing less than or equal to grade 1). Absence of any local conditions affecting bone-implant osseointegration (e.g., infection and poor bone density). The presence of sufficient bone width and height that permit the placement of implant with minimum diameter 3.5 mm and 8.5 mm length. Exclusion Criteria: Presence of acute infections. Smokers. Pregnancy and lactation. Patients with a history of bisphosphonates therapy.

Sites / Locations

  • Ain Shams University -Faculty of dentistry

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

laser group

plasma group

control group

Arm Description

Healing abutments have been treated by Er:YAG laser. The laser-machine (with a wavelength of 2.940 nm) was used with settings of 100 mJ/pulse (12.7 J/cm₂) and 10 Hz. The healing abutments' surface was thoroughly decontaminated by the fiber tip in a semicircular contact mode with copious water irrigation.

Healing abutments have been sprayed with an atmospheric pressure plasma device (Piezobrush® PZ2) , by using active gas, low-temperature plasma treatment under irradiation at 0.2 MPa for a total of 80 seconds at 10 mm (20 seconds per each surface)

Healing abutments were installed as they came from industry and received no further treatment.

Outcomes

Primary Outcome Measures

histological assessment measuring inflammatory cells count.
sections of biopsies from peri-implant soft tissue stained with hematoxylin and eosin stain. H&E stain was used for measuring inflammatory cells count and Masson's Trichrome stains for measuring collagen fibers area fraction.
histological assessment measuring collagen fibers area fraction.
sections of biopsies from peri-implant soft tissue stained with Masson trichrome stain.

Secondary Outcome Measures

scanning electron microscopic analysis
Analysis of the abutments surface was done using SEM
clinical assessment measuring plaque index
Clinical assessment was done using loe and silness plaque index score from 0 to 3
clinical assessment measuring gingival index
Clinical assessment was done using loe and silness gingival index score from 0 to 3

Full Information

First Posted
March 5, 2023
Last Updated
April 4, 2023
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT05800795
Brief Title
Evaluation of Soft Tissue Response to Titanium Healing Abutments Treated by Erbium: YAG Laser or Plasma Spray
Official Title
Evaluation of Soft Tissue Response to Titanium Healing Abutments Treated by Erbium: YAG Laser or Plasma Spray: A Randomized Controlled Clinical Study With Histological, and Scanning Electron Microscopic Analysis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
June 20, 2021 (Actual)
Primary Completion Date
June 13, 2022 (Actual)
Study Completion Date
September 22, 2022 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The attachment of peri implant soft tissue to the implant serves as a biological seal that can prevent the development of inflammatory peri-implant diseases. Presence of contaminants has been suggested to be associated with tissue damaging inflammation and titanium wear microparticles were demonstrated to activate osteoclastic action. Er: YAG laser has been extensively investigated clinically for applications for treating periimplantitis either independently or in combination with other techniques, showing favorable outcomes. Plasma spray treatment can decontaminate surfaces without modifying their topography. It is also able to increase the surface energy by obtaining more hydrophilic surfaces, which may increase the capacity of the titanium oxide layer to interact with cells and proteins of surrounding tissue improving cell adhesion to the treated surface.
Detailed Description
This study was conducted on 24 patients seeking implant placement. A total number of 33 healing abutments were included in this study, they were divided into 3 groups. Group 1 (Laser group): 8 patients in this group received 11 healing abutments treated with Er:YAG laser, group 2 (Plasma group): 8 patients in this group received 11 healing abutments treated with plasma sprayand group 3 (control group): 8 patients in this group received 11 healing abutments with no surface treatment.Three months after implants placement, patients included in the study were randomly assigned to one of the three study groups, second stage surgery was performed and patients received healing abutments without surface treatment in control group, surface treatment was performed in plasma and laser groups. After two weeks, clinical assessment was done using PI and GI before taking biopsies from peri-implant soft tissue for histological assessment. H&E stain was used for measuring inflammatory cells count and Masson's Trichrome stains for measuring collagen fibers area fraction. Analysis of the abutments surface was done using SEM.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peri-implant Mucositis
Keywords
healing abutment, plasma spray, Er: YAG laser

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
comparison between three groups
Masking
Outcomes Assessor
Masking Description
assessor of clinical parameters, histological samples and scanning electron microscopy samples
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
laser group
Arm Type
Active Comparator
Arm Description
Healing abutments have been treated by Er:YAG laser. The laser-machine (with a wavelength of 2.940 nm) was used with settings of 100 mJ/pulse (12.7 J/cm₂) and 10 Hz. The healing abutments' surface was thoroughly decontaminated by the fiber tip in a semicircular contact mode with copious water irrigation.
Arm Title
plasma group
Arm Type
Active Comparator
Arm Description
Healing abutments have been sprayed with an atmospheric pressure plasma device (Piezobrush® PZ2) , by using active gas, low-temperature plasma treatment under irradiation at 0.2 MPa for a total of 80 seconds at 10 mm (20 seconds per each surface)
Arm Title
control group
Arm Type
No Intervention
Arm Description
Healing abutments were installed as they came from industry and received no further treatment.
Intervention Type
Device
Intervention Name(s)
Er: YAG laser
Intervention Description
surface treatment with Er: YAG laser for heating abutments
Intervention Type
Device
Intervention Name(s)
plasma spray
Intervention Description
surface treatment with plasma spray for heating abutments
Primary Outcome Measure Information:
Title
histological assessment measuring inflammatory cells count.
Description
sections of biopsies from peri-implant soft tissue stained with hematoxylin and eosin stain. H&E stain was used for measuring inflammatory cells count and Masson's Trichrome stains for measuring collagen fibers area fraction.
Time Frame
two weeks after stage two surgery
Title
histological assessment measuring collagen fibers area fraction.
Description
sections of biopsies from peri-implant soft tissue stained with Masson trichrome stain.
Time Frame
two weeks after stage two surgery
Secondary Outcome Measure Information:
Title
scanning electron microscopic analysis
Description
Analysis of the abutments surface was done using SEM
Time Frame
two weeks after stage two surgery
Title
clinical assessment measuring plaque index
Description
Clinical assessment was done using loe and silness plaque index score from 0 to 3
Time Frame
two weeks after stage two surgery and after three months
Title
clinical assessment measuring gingival index
Description
Clinical assessment was done using loe and silness gingival index score from 0 to 3
Time Frame
two weeks after stage two surgery and after three months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and female patients with age range from 20 to 45 years old. Patients need placement of fixed implant-supported prosthesis in maxillary arch. Patients who are medically free from any systemic diseases as evidenced by the health questionnaire, using modified Cornell medical index (Pendleton et al., 2004). patients with good oral hygiene (Plaque Index and bleeding on probing less than or equal to grade 1). Absence of any local conditions affecting bone-implant osseointegration (e.g., infection and poor bone density). The presence of sufficient bone width and height that permit the placement of implant with minimum diameter 3.5 mm and 8.5 mm length. Exclusion Criteria: Presence of acute infections. Smokers. Pregnancy and lactation. Patients with a history of bisphosphonates therapy.
Facility Information:
Facility Name
Ain Shams University -Faculty of dentistry
City
Cairo
ZIP/Postal Code
1156
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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Evaluation of Soft Tissue Response to Titanium Healing Abutments Treated by Erbium: YAG Laser or Plasma Spray

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