Different Treatment Modalities for Atrophied Distal Extension Maxillary Ridges

Not Applicable

• Conditions: Partial Edentulism Class 1
• Interventions: Procedure: Long implant and partial overdentures; Procedure: short implant without sinus lift; Procedure: Sinus lift and long implant; Device: Partial overdentures; Device: Metal ceramic prosthesis on long implants; Device: Metal ceramic prosthesis on short implants

• Registration Number: NCT05198687
• Lead Sponsor: Mansoura University

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

Patients were not eligible for this work if any of the following criteria were met:

* 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....). All patient were informed about all procedures that will be done and they sign the written consent form of ethical committee in faculty of dentistry Mansoura university.

Three treatment groups will be classified randomly, as follow:

* Group A: patients received two implant in premolar area mesial to maxillary sinus and used to retain partial overdenture

* Group B: patient underwent sinus lift and receive screw retained prosthesis on long implant

* Group C: patients received short implants in premolar area mesial to maxillary sinus and received screw retained prothesis All implants were inserted using computer guided implant surgery and conventional loading protocol was used.

Evaluation methods Clinical and radiographic evaluation

1. Modified Plaque index. Assessment of plaque accumulation with a modified plaque index (mPI): Score 0: No detection of plaque, Score 1: Plaque only recognized by running a probe across the smooth marginal surface of the implant, Score 2 Plaque can be seen by a naked eye, Score 3 Abundance of soft matter.

2. Gingival index. Assessment of bleeding tendency with a modified sulcus bleeding index (mBI): Score 0 No bleeding when a periodontal probe is passed along the gingival margin adjacent to the implant. Score 1 Isolated bleeding spot visible, Score 2 Blood forms a confluent red line on margin, Score 3 Heavy or profuse bleeding.

3. Attachment level. Distance from the junction implant/crown to the most apically probeable portion, in millimeters.

4. Pocket depth. Distance between the gingival margin and the most apically probable portion, in millimeters Assessed by insertion of a standard periodontal probe with a point diameter of 0.5 mm using a probing force of 0.5 N.

5. Implant stability quotient. Using resonance frequency analysis

b- Radiographic evaluation will be performed in terms of:

Vertical bone loss (VBL) will be evaluated as follows:

The distance between implant plate form and first bone to implant contact (DIM) will be evaluated at T0, T6 and T12. VBL will be calculated by subtracting DIM at T6 and T12 from DIM at T0.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-03-01
• Primary Completion: 2021-05-01
• Status Verified: 2021-09
• Study First Submitted: 2021-09-24
• Study First Submitted QC: 2022-01-06
• Study First Posted: 2022-01-20
• Last Update Submitted: 2022-02-27
• Last Update Posted: 2022-03-02
• Study Completion: 2022-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

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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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
overdentures	Long implant and partial overdentures	implant overdentures
overdentures	Partial overdentures	implant overdentures
short implants	short implant without sinus lift	short implants and screw-retained prosthesis
sinus lift	Metal ceramic prosthesis on long implants	sinus lift and long implants and screw-retained prosthesis
sinus lift	Sinus lift and long implant	sinus lift and long implants and screw-retained prosthesis
short implants	Metal ceramic prosthesis on short implants	short implants and screw-retained prosthesis

Primary Outcome Measures

Name	Time	Method
Plaque index	one year	measuring plaque accumulation around implants using scores
Gingival index	one year	measuring gingival inflammation around implants using scores
Marginal bone loss	one year	measuring crestal bone loss around implants in mm
Probing depth	one year	measuring peri-implant probing depth in mm
implant stability	one year	measuring the mobility of the implants using resonance frequency analysis Implant stability quotient)
Patient satisfaction using VAS questionnaire (visual analogue scale)	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 Outcome Measures

Name	Time	Method
Muscle activity	one year	measure muscles activity in amplitude using electromyographs
Prosthetic Aspects	one year	measuring the incidence of prosthetic aspects and maintenance requirements
maximum bite force	one year	measuring maximum bite force in newton using bite force transducers

Trial Locations

Locations (1)

Faculty of Dentistry, Mansoura University; 🇪🇬 Mansoura, Eldakahlia, Egypt