Effect of Laser Biostimulation With Mandibular Ridge Splitting and Peek Overdenture

Ridge Splitting Clinical Trial

Official title:

Effect of Laser Bio-stimulation on Peri-implant Tissue Health for Mandibular Knife-edge Ridges Managed With One- Stage Ridge Splitting and Two- Implant Mandibular PEEK Overdentures. A One -Year Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05837078
• Other study ID #: A01100918
• Status: Completed
• Phase: N/A
• Start date: April 20, 2019
• Est. completion date: October 19, 2022

Study information

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

Clinical Trial Summary

This study was conducted to determine the effectiveness of two-implant retained polyetheretherketone (PEEK) overdentures on reducing the transmitted forces on implants placed with ridge splitting either treated with laser biostimulation or not.

Description:

This randomised controlled trial was executed on 18 completely edentulous patients from the Outpatient Clinic of the Faculty of Dentistry at Mansoura University in Egypt.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: October 19, 2022
• Est. primary completion date: January 13, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 60 Years

Eligibility

Inclusion Criteria:

• eligible patients must have mandibular knife edge ridge

Exclusion Criteria:

• contraindicated any systemic disease preventing surgical intervention such as bone metabollic disease , diabetes mellitus

Related Conditions & MeSH terms

• Ridge Splitting

Intervention

Procedure:
• ridge splitting with implant placement
ridge splitting of mandibular denture followed by two implant placement

Locations

Country	Name	City	State
Egypt	Marwa Adel	Mansoura	Dakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	crestal bone loss	measuring marginal bone loss arround dental implants in mm by digital radiograph	one year
Primary	plaque index	score 0 = no plaque; score1 = plaque only detected with a probe; score 2 = plaque visible to the naked eye; score 3 = abundant plaque1111	One year
Primary	bleeding index	score 0: no bleeding when using a periodontal probe; score1: isolated bleeding spots visible; score 2: a confluent red line of blood along the mucosal margin; score 3: heavy or profuse bleeding).	one year
Primary	gingival index	Score 0: normal peri implant mucosa; score 1: mild inflammation, slight colour change, and slight edoema; score 2: moderate inflammation, redness, edoema, and glazing; and score 3: severe inflammation, marked redness and edoema, and ulceration.	one year
Primary	probing depth	A periodontal probe was used to measure pocket depth (PD). The distance between the marginal border of the mucosa and the tip of the periodontal probe at the base of the gingival sulcus was scored as the probing depth.	one year