Skip to main content
Clinical Trials/NCT05198687
NCT05198687UnknownNot Applicable

Comparison Between Three Different Treatment Modalities for Atrophied Distal Extension Maxillary Ridges Clinical and Radiographic Study

Mansoura University1 site in 1 country60 target enrollmentStarted: March 1, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
60
Locations
1
Primary Endpoint
Plaque index

Study Overview

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

Detailed Description

Patient selection:

For this study, 60 patients were selected from the clinic of Prosthodontic Department, Faculty of Dentistry, Mansoura University.

Inclusion criteria:

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. Exclusion criteria

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •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.

Exclusion Criteria

  • •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

Arms & Interventions

overdentures

Active Comparator

implant overdentures

Intervention: Long implant and partial overdentures (Procedure)

overdentures

Active Comparator

implant overdentures

Intervention: Partial overdentures (Device)

sinus lift

Active Comparator

sinus lift and long implants and screw-retained prosthesis

Intervention: Sinus lift and long implant (Procedure)

sinus lift

Active Comparator

sinus lift and long implants and screw-retained prosthesis

Intervention: Metal ceramic prosthesis on long implants (Device)

short implants

Active Comparator

short implants and screw-retained prosthesis

Intervention: short implant without sinus lift (Procedure)

short implants

Active Comparator

short implants and screw-retained prosthesis

Intervention: Metal ceramic prosthesis on short implants (Device)

Outcomes

Primary Outcomes

Plaque index

Time Frame: one year

measuring plaque accumulation around implants using scores

Gingival index

Time Frame: one year

measuring gingival inflammation around implants using scores

Marginal bone loss

Time Frame: one year

measuring crestal bone loss around implants in mm

Probing depth

Time Frame: one year

measuring peri-implant probing depth in mm

implant stability

Time Frame: one year

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

Patient satisfaction using VAS questionnaire (visual analogue scale)

Time Frame: 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.

Secondary Outcomes

  • Muscle activity(one year)
  • Prosthetic Aspects(one year)
  • maximum bite force(one year)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

Loading locations...

Similar Trials

Different Treatment Modalities for... | Clinical Trial