Evaluation of Marginal Bone Loss of Two Immediately Loaded Implants Retaining Mandibular Overdenture

NCT06150755 | Unknown DMC

• 1 other identifier: FDASU-RecID032118
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

It is a randomized control clinical trial in which maxillary and mandibular dentures will be constructed, two implants will be inserted in the inter foraminal region in the edentulous mandible and immediate loading will be done. We will be comparing peri-implant marginal bone loss of two immediately loaded implants retaining mandibular overdentures with ball attachment versus intra oral welding titanium bar. Patient satisfaction will be assessed using oral health related quality of life.

Conditions

Edentulous Alveolar Ridge

Outcome Measures

Primary Outcomes (1)

• marginal bone loss measurement

  marginal bone loss will be measured mesial and distal to the implant by radiographic cone paralling technique

  6 months

Secondary Outcomes (1)

• patient satisfaction

  6 months

Study Arms (2)

mplant supported overdenture by ball attachment

PLACEBO COMPARATOR

immediate loaded implant supported overdenture by ball attachment

Procedure: implant supported overdenture by ball

implant supported overdenture by bar

ACTIVE COMPARATOR

immediate loaded implant supported overdenture by intraoral welding titanium bar splinted two implant

Procedure: implant supported overdenture by bar

Interventions

implant supported overdenture by ball PROCEDURE

overdenture supported by two implant with ball attachment

mplant supported overdenture by ball attachment

implant supported overdenture by bar PROCEDURE

overdenture supported by two implant splinted by intraoral welding titanuim bar

implant supported overdenture by bar

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• good oral hygiene
• patient will be medically free
• sufficient inter arch space

You may not qualify if:

• heavy smoker
• TMJ disorders
• uncontrolled diabetes
• flappy tissue

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of Dentistry Ain Shams University

Cairo, 11361, Egypt

Location

Study Officials

• Ahmed MA Mohamed, BDS MSc MD

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed MA Mohamed, BDS MSc,MD

CONTACT

01111191337; ahmedmostafa@dent.asu.edu.eg

Amr MO El fikky, BDS MSc

CONTACT

01144224292; aaa.fiky@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinding will be done by the outcomes assessor and one of the study authors will remove the prosthetic part before measuring crestal bone loss by outcome assessor through cone paralling technique. Blinding of the outcomes assessor for assessment by oral health questionnaire will be done as well
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor of oral and maxillofacial prosthodontics

Model Details: completely edentulous patients treated with overdenture retained by immediately loaded implant in the canine region

Study Record Dates

• First Submitted: November 21, 2023
• First Posted: November 29, 2023
• Study Start: December 24, 2023
• Primary Completion: July 1, 2024
• Study Completion: August 10, 2024
• Last Updated: December 11, 2023

Record last verified: 2023-12

Locations

EG (1)