Two Versus Four Implant-supported Fixed Full-arch Prosthesis

Sponsor
Mansoura University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05290766
Collaborator
(none)
30
2
2
18.9
15
0.8

Study Details

Study Description

Brief Summary

The aim of this study will be the evaluation of patient satisfaction and oral health-related-quality of life (OHRQoL) of two versus four implants supporting fixed full-arch screw-retained metal acrylic hybrid mandibular prosthesis.

Condition or Disease Intervention/Treatment Phase
  • Procedure: placement of four dental implants
  • Procedure: placement of two dental implants
  • Device: mandibular full arch prosthesis
N/A

Detailed Description

  • Six completely edentulous patients will be selected for this study from the outpatient clinic of the prosthodontic department

  • All patients will be informed about all surgical and prosthodontics procedures that will be done for them. All patients will sign the consent form of the ethical committee in faculty dentistry Mansoura University.

The patients will be divided into 2 groups

  1. Control group: will receive implant-supported mandibular fixed metal acrylic prosthesis on 4 implants that were placed according to the "All on four concept".

  2. Study group: will receive implant-supported mandibular fixed metal acrylic prosthesis on two implants placed according to "All On two concept".

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Two Versus Four Implant Supporting Fixed Full-arch Screw-retained Metal Acrylic Hybrid Mandibular Prosthesis.(A Study of Patient Satisfaction)
Actual Study Start Date :
Jan 4, 2022
Anticipated Primary Completion Date :
Feb 1, 2023
Anticipated Study Completion Date :
Aug 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Control group

will receive implant-supported mandibular fixed metal acrylic prosthesis on 4 implants that were placed according to the "All on four concept".

Procedure: placement of four dental implants
placement of four dental implants according to the " All on four concept"

Device: mandibular full arch prosthesis
loading of the mandibular fixed full-arch screw-retained metal acrylic prosthesis

Active Comparator: Study group

will receive implant-supported mandibular fixed metal acrylic prosthesis on two implants placed according to "All On two concept".

Procedure: placement of two dental implants
placement of two dental implants according to " All on two concepts"

Device: mandibular full arch prosthesis
loading of the mandibular fixed full-arch screw-retained metal acrylic prosthesis

Outcome Measures

Primary Outcome Measures

  1. Visual analog scale (VAS) questionnaire [one year]

    Regarding VAS, participants were asked to score their answer according to the amount of satisfaction on a 100mm line (Score zero = no satisfaction at all and score 100 = complete satisfaction). The questions cover several items related to prosthesis such as: retention, stability, comfort, ease of cleaning, ease of speaking, ease of chewing, limited activities due to embarrassment, quality of bolus and appearance

  2. crestal bone loss [one year]

    measuring marginal bone loss in mm around dental implants by digital radiography

  3. plaque index [one year]

    evaluation of plaque accumulation around dental implants using scores.score 0; absence plaque , score 1; plaque only detected by a probe passing through the smooth marginal surface of the implant, score 2; plaque can be recognized by naked eye, and score 3; plenty of soft matter

  4. gingival index [one year]

    evaluation of gingival bleeding using scoring system as following: scores.0; no bleeding when a periodontal probe is passed along the mucosal margin, 1;isolated bleeding spots visible, 2; blood forms a confluent red line on the mucosal margin, 3;heavy or profuse bleeding.

  5. pocket depth [one year]

    evaluation of pocket depth in mm around dental implants

Secondary Outcome Measures

  1. Quality of Life (Secondary Outcome). [one year]

    The oral Health impact profile (OHIP-14) questions were utilized to assess OHRQoL. The questions were composed of seven domains

  2. prosthesis maintenance and survival rate [one year]

    measuring the survival rate of the mandibular prosthesis in both groups

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • • Eligible patients needed must have Sufficient interarch space (at least 15 mm from the occlusal plane to the mandibular ridge) to provide space for fixed prosthesis construction all patients should be completely edentulous patients with resorbed mandibular ridge all patients must be angle class I
Exclusion Criteria:
  • systemic diseases that contraindicate implant placement bone metabolic diseases such as diabetes mellitus irradiation of the head and neck region chemotherapy within the past 3 years smoking habits.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of Dentistry, Mansoura University Mansoura Eldakahlia Egypt 35516
2 Christine Ibrahim Mansoura Egypt P.O.Box:35516

Sponsors and Collaborators

  • Mansoura University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mansoura University
ClinicalTrials.gov Identifier:
NCT05290766
Other Study ID Numbers:
  • A03040122
First Posted:
Mar 22, 2022
Last Update Posted:
Mar 22, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 22, 2022