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Completed

NCT Number: NCT05800795

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

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.

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Key information

Conditions

Peri-implant Mucositis

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University -Faculty of dentistry

Cairo, 1156, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Er: YAG laser

Device

surface treatment with Er: YAG laser for heating abutments

plasma spray

Device

surface treatment with plasma spray for heating abutments

Primary outcomes

  1. histological assessment measuring inflammatory cells count.

    Time frame: two weeks after stage two surgery

    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.

  2. histological assessment measuring collagen fibers area fraction.

    Time frame: two weeks after stage two surgery

    sections of biopsies from peri-implant soft tissue stained with Masson trichrome stain.

Secondary outcomes

  1. scanning electron microscopic analysis

    Time frame: two weeks after stage two surgery

    Analysis of the abutments surface was done using SEM

  2. clinical assessment measuring plaque index

    Time frame: two weeks after stage two surgery and after three months

    Clinical assessment was done using loe and silness plaque index score from 0 to 3

  3. clinical assessment measuring gingival index

    Time frame: two weeks after stage two surgery and after three months

    Clinical assessment was done using loe and silness gingival index score from 0 to 3

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 6, 2023
Registry last updated
Apr 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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