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Completed

NCT Number: NCT05837078

Effect of Laser Biostimulation With Mandibular Ridge Splitting and Peek Overdenture

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.

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Key information

Conditions

Ridge Splitting

Age range

50 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marwa Adel

Al Mansurah, Dakahlia Governorate, 35511, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

ridge splitting with implant placement

Procedure

ridge splitting of mandibular denture followed by two implant placement

Primary outcomes

  1. crestal bone loss

    Time frame: one year

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

  2. plaque index

    Time frame: One year

    score 0 = no plaque; score1 = plaque only detected with a probe; score 2 = plaque visible to the naked eye; score 3 = abundant plaque1111

  3. bleeding index

    Time frame: one year

    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).

  4. gingival index

    Time frame: one year

    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.

  5. probing depth

    Time frame: one year

    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.

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
May 1, 2023
Registry last updated
May 1, 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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