Different Treatment Modalities for Atrophied Distal Extension Maxillary Ridges

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Partial Edentulism Class 1
• Intervention / Treatment: Procedure: Long implant and partial overdentures; Device: Partial overdentures; Procedure: Sinus lift and long implant; Device: Metal ceramic prosthesis on long implants; Procedure: short implant without sinus lift; Device: Metal ceramic prosthesis on short implants

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Eldakahlia
    • Mansoura, Eldakahlia, Egypt, 35516
      • Faculty of Dentistry, Mansoura University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: overdentures; implant overdentures	Procedure: Long implant and partial overdentures; insertion of long implants anterior to the maxillary sinus to retain partial overdentures; Device: Partial overdentures; Distal extension metallic partial dentures retained by attachments to the implants
ACTIVE_COMPARATOR: sinus lift; sinus lift and long implants and screw-retained prosthesis	Procedure: Sinus lift and long implant; performing sinus lift surgical procedure with simultaneous placement of long implants to support screw-retained prosthesis; Device: Metal ceramic prosthesis on long implants; porcelain fused to metal fixed screw-retained prosthesis supported by long implants
ACTIVE_COMPARATOR: short implants; short implants and screw-retained prosthesis	Procedure: short implant without sinus lift; placement of short implants in the remaining bone above maxillary sinus to support screw-retained prosthesis without performing sinus lift; Device: Metal ceramic prosthesis on short implants; porcelain fused to metal fixed screw-retained prosthesis supported by short implants

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2020
• Primary Completion (ACTUAL): May 1, 2021
• Study Completion (ANTICIPATED): June 1, 2022

Study Registration Dates

• First Submitted: September 24, 2021
• First Submitted That Met QC Criteria: January 6, 2022
• First Posted (ACTUAL): January 20, 2022

Study Record Updates

• Last Update Posted (ACTUAL): March 2, 2022
• Last Update Submitted That Met QC Criteria: February 27, 2022
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Atrophy
• Other Study ID Numbers: M06030320

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No