Different Treatment Modalities for Atrophied Distal Extension Maxillary Ridges

NCT05198687 | Unknown

• 1 other identifier: M06030320
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study will compare clinical and radiographic outcomes of three different treatment modalities for atrophied distal extension maxillary ridges these modalities include

1. 1.Implant retained distal extension RPD
2. 2.Sinus lift and long implant and screw-retained prosthesis
3. 3.Short implant and screw-retained prosthesis

Conditions

Partial Edentulism Class 1

Outcome Measures

Primary Outcomes (6)

• Plaque index

  measuring plaque accumulation around implants using scores

  one year

• Gingival index

  measuring gingival inflammation around implants using scores

  one year

• Probing depth

  measuring peri-implant probing depth in mm

  one year

• implant stability

  measuring the mobility of the implants using resonance frequency analysis Implant stability quotient)

  one year

• Marginal bone loss

  measuring crestal bone loss around implants in mm

  one year

• Patient satisfaction using VAS questionnaire (visual analogue scale)

  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.

  one year

Secondary Outcomes (3)

• Prosthetic Aspects

  one year

• Muscle activity

  one year

• maximum bite force

  one year

Study Arms (3)

overdentures

ACTIVE COMPARATOR

implant overdentures

Procedure: Long implant and partial overdentures; Device: Partial overdentures

sinus lift

ACTIVE COMPARATOR

sinus lift and long implants and screw-retained prosthesis

Procedure: Sinus lift and long implant; Device: Metal ceramic prosthesis on long implants

short implants

ACTIVE COMPARATOR

short implants and screw-retained prosthesis

Procedure: short implant without sinus lift; Device: Metal ceramic prosthesis on short implants

Interventions

Long implant and partial overdentures PROCEDURE

insertion of long implants anterior to the maxillary sinus to retain partial overdentures

overdentures

Sinus lift and long implant PROCEDURE

performing sinus lift surgical procedure with simultaneous placement of long implants to support screw-retained prosthesis

sinus lift

short implant without sinus lift PROCEDURE

placement of short implants in the remaining bone above maxillary sinus to support screw-retained prosthesis without performing sinus lift

short implants

Partial overdentures DEVICE

Distal extension metallic partial dentures retained by attachments to the implants

overdentures

Metal ceramic prosthesis on long implants DEVICE

porcelain fused to metal fixed screw-retained prosthesis supported by long implants

sinus lift

Metal ceramic prosthesis on short implants DEVICE

porcelain fused to metal fixed screw-retained prosthesis supported by short implants

short implants

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• The patients will be selected according to the following:
• They have distal extension maxillary ridge with sinus pneumatization and remaining alveolar bone height 6- 8mm as verified by preoperative CBCT, have no previous denture experience. They are healthy, free from any systemic diseases relating to the bone resorption (diabetes - hyperparathyroidism). This can be achieved through medical history and clinical examination by a physician and laboratory investigations.
• Posterior maxillary alveolar ridge deficient in height, width and covered with healthy firm mucosa.
• Patients are less satisfied with conventional RPD.
• Absence of maxillary sinus diseases.

You may not qualify if:

• Acute or chronic sinus pathology
• History of a sinus augmentation in the past in the relevant sinus
• Poor dental hygiene. Smoker.
• Compromised general health (uncontrolled diabetes, bleeding disorder

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Faculty of Dentistry, Mansoura University

Al Mansurah, Eldakahlia, 35516, Egypt

Location

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: SPONSOR

Study Record Dates

• First Submitted: September 24, 2021
• First Posted: January 20, 2022
• Study Start: March 1, 2020
• Primary Completion: May 1, 2021
• Study Completion: June 1, 2022
• Last Updated: March 2, 2022

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

EG (1)