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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05800795
Enrollment
24
Registered
2023-04-06
Start date
2021-06-20
Completion date
2022-09-22
Last updated
2023-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peri-implant Mucositis

Keywords

healing abutment, plasma spray, Er: YAG laser

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.

Interventions

surface treatment with Er: YAG laser for heating abutments

DEVICEplasma spray

surface treatment with plasma spray for heating abutments

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

assessor of clinical parameters, histological samples and scanning electron microscopy samples

Intervention model description

comparison between three groups

Eligibility

Sex/Gender
ALL
Age
20 Years to 45 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
histological assessment measuring collagen fibers area fraction.two weeks after stage two surgerysections of biopsies from peri-implant soft tissue stained with Masson trichrome stain.
histological assessment measuring inflammatory cells count.two weeks after stage two surgerysections 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.

Secondary

MeasureTime frameDescription
scanning electron microscopic analysistwo weeks after stage two surgeryAnalysis of the abutments surface was done using SEM
clinical assessment measuring plaque indextwo weeks after stage two surgery and after three monthsClinical assessment was done using loe and silness plaque index score from 0 to 3
clinical assessment measuring gingival indextwo weeks after stage two surgery and after three monthsClinical assessment was done using loe and silness gingival index score from 0 to 3

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026