Effect of Laser Biostimulation With Mandibular Ridge Splitting and Peek Overdenture

NCT05837078 | Completed

• 1 other identifier: A01100918
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ridge Splitting

Keywords

peek , laser

Outcome Measures

Primary Outcomes (5)

• crestal bone loss

  measuring marginal bone loss arround dental implants in mm by digital radiograph

  one year

• 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

• 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

• 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

• 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

Study Arms (2)

control group

ACTIVE COMPARATOR

patients had ridge splitting without laser bio stimulation and received two implants supported peek overdenture

Procedure: ridge splitting with implant placement

study group

ACTIVE COMPARATOR

patients had ridge splitting with laser bio stimulation and received two implants supported peek overdenture

Procedure: ridge splitting with implant placement

Interventions

ridge splitting with implant placement PROCEDURE

ridge splitting of mandibular denture followed by two implant placement

control group; study group

Eligibility Criteria

• Age: 50 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- eligible patients must have mandibular knife edge ridge

You may not qualify if:

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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Marwa Adel

Al Mansurah, Dakahlia Governorate, 35511, Egypt

Location

Study Officials

• marwa adel, MD

  Mansoura University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer

Study Record Dates

• First Submitted: April 19, 2023
• First Posted: May 1, 2023
• Study Start: April 20, 2019
• Primary Completion: January 13, 2021
• Study Completion: October 19, 2022
• Last Updated: May 1, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)