Clinical trial NCT05800795: 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
Overall status: COMPLETED
Phase: NA
Conditions: Peri-implant Mucositis
Keywords: healing abutment
plasma spray
Er: YAG laser
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-04-06
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: comparison between three groups
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: histological assessment measuring inflammatory cells count.
timeFrame: two weeks after stage two surgery
measure: histological assessment measuring collagen fibers area fraction.
timeFrame: two weeks after stage two surgery
Secondary outcomes:
measure: scanning electron microscopic analysis
timeFrame: two weeks after stage two surgery
measure: clinical assessment measuring plaque index
timeFrame: two weeks after stage two surgery and after three months
measure: clinical assessment measuring gingival index
timeFrame: two weeks after stage two surgery and after three months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University -Faculty of dentistry
Study officials:
References: