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

Peri-implant Mucositis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05800795
• Other study ID #: FDASU-RecID021817
• Status: Completed
• Phase: N/A
• Start date: June 20, 2021
• Est. completion date: September 22, 2022

Study information

• Verified date: April 2023
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: September 22, 2022
• Est. primary completion date: June 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mucositis
• Peri-implant Mucositis

Intervention

Device:
• Er: YAG laser
surface treatment with Er: YAG laser for heating abutments
• plasma spray
surface treatment with plasma spray for heating abutments

Locations

Country	Name	City	State
Egypt	Ain Shams University -Faculty of dentistry	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	two weeks after stage two surgery
Primary	histological assessment measuring collagen fibers area fraction.	sections of biopsies from peri-implant soft tissue stained with Masson trichrome stain.	two weeks after stage two surgery
Secondary	scanning electron microscopic analysis	Analysis of the abutments surface was done using SEM	two weeks after stage two surgery
Secondary	clinical assessment measuring plaque index	Clinical assessment was done using loe and silness plaque index score from 0 to 3	two weeks after stage two surgery and after three months
Secondary	clinical assessment measuring gingival index	Clinical assessment was done using loe and silness gingival index score from 0 to 3	two weeks after stage two surgery and after three months