search
Back to results

Management of Distally Extension Maxillary Atrophied Ridge With Two Different Minimal Invasive Treatment Modalities

Primary Purpose

Partial Edentulism Class 2 Due to Periodontal Disease

Status
Active
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Closed sinus lift procedure
Crestal sinus lift
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Partial Edentulism Class 2 Due to Periodontal Disease

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: The patients will be selected according to the following: They have atrophied unilateral distal extension maxillary ridge and remaining alveolar bone height 6- 8mm as verified by preoperative CBCT, 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

implant retained removable overdentures

implant supported fixed screw retained prosthesis

Arm Description

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

Procedure: Sinus lift and long implant performing sinus lift surgical procedure with simultaneous placement of limplants to support screw-retained prosthesis Device: Metal ceramic prosthesis on long implants porcelain fused to metal fixed screw-retained prosthesis supported by implants

Outcomes

Primary Outcome Measures

Plaque index evaluation
measuring plaque accumulation around implants using scores Plaque will be assessed according to modified plaque index describe as follows: score 0; no plaque detected, score 1; plaque recognized only by running a probe across a smooth marginal surface of the implant, score 2; plaque can be seen by naked eye, and score 3; abundance of soft mater.
Gingival index evaluation
measuring inflammation around implants using scores Modified index will be recorded as follows: score 0; normal , score 1; mild inflammation (slight change in color & slight edema), but no bleeding on probing, score 2; moderate inflammation (redness & edema), and bleeding on probing, and score 3; sever inflammation (marked redness, edema & ulceration) with tendency to spontaneous bleeding.
Probing depth evaluation
measuring per-implant probing depth in mm. Using a calibrated plastic periodontal probe, the distance between marginal border of the and the tip of the probe was measured in mm and considered as pocket depth.
Implant stability evaluation
measuring the mobility of the implants using resonance frequency analysis Implant stability quotient) The resonance frequencies will be measured with the osstell® device (implant stability meter) and will be expressed with measurement scale (implant stability quotient).
Radio graphic evaluation
measuring bone loss around implants in mm Radio-graphs were taken using direct digital imaging system - Marginal alveolar bone changes (vertical and horizontal bone loss) were measured at medial and distal surface of each implant in mm.
Patient satisfaction
Patient satisfaction using questionnaire (visual analogue scale) Patient satisfaction was evaluated using a questionnaire based on visual analog scale . Patients were asked to mark their answer (amount of satisfaction) on a 100-mm line (with zero refers to not satisfied at all and 100 refers to completely satisfied). The mean of the answers (length of the lines from zero to the marks in mm) for each question. 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 was subjected to statistical analysis

Secondary Outcome Measures

Prosthetic complication
incidence of prosthetic aspects and maintenance requirements
Muscle activity
Muscle activity measure muscles activity in amplitude using electromyographs
maximum bite force
measuring maximum bite force in newton using bite force transducers

Full Information

First Posted
November 17, 2022
Last Updated
April 20, 2023
Sponsor
Mansoura University
search

1. Study Identification

Unique Protocol Identification Number
NCT05646498
Brief Title
Management of Distally Extension Maxillary Atrophied Ridge With Two Different Minimal Invasive Treatment Modalities
Official Title
Clinical and Patient- Satisfaction Outcomes During Management of Atrophied Unilateral Distally Extension Maxillary Ridge With Two Different Minimal Invasive Treatment Modalities. 1-year Randomized Controlled Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 21, 2021 (Actual)
Primary Completion Date
June 17, 2022 (Actual)
Study Completion Date
June 22, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will compare clinical and radio graphic outcomes of two minimally invasive different treatment modalities for atrophied unilateral distal extension maxillary ridges these modalities include Medially placed implant and Implant retained distal extension removable partial denture Sinus lift and long implant to support fixed screw-retained prosthesis
Detailed Description
Patient selection: For this study, 40 patients were selected from the clinic of Prosthodontics Department, Faculty of Dentistry, Mansoura University. Inclusion criteria: The patients will be selected according to the following: They have atrophied unilateral distal extension maxillary ridge and remaining alveolar bone height 6- 8 mm as verified by preoperative cone beam. 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 covering. Patients are less satisfied with conventional removable partial denture. 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 I: patients received one implant in premolar area medial to maxillary sinus and used to retain partial over-denture. Group II: patient underwent sinus lift and receive screw retained prosthesis on long implant All implants were inserted using computer guided and flap-less implant surgery and conventional loading protocol was used. Evaluation methods Clinical and radio-graphic evaluation Modified Plaque index. Assessment of plaque accumulation with a modified plaque index : 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. Marginal index. Assessment of bleeding tendency with a modified bleeding index : Score 0 No bleeding when a periodontal probe is passed along the 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. Attachment level. Distance from the junction implant/crown to the most apically probe able portion, in millimeters. Pocket depth. Distance between the 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. Implant stability quotient. Using resonance frequency analysis b- Radio-graphic evaluation will be performed in terms of: Vertical bone loss will be evaluated as follows: The distance between implant plate form and first bone to implant contact will be evaluated after one year.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Partial Edentulism Class 2 Due to Periodontal Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
implant retained removable overdentures
Arm Type
Active Comparator
Arm Description
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
Arm Title
implant supported fixed screw retained prosthesis
Arm Type
Active Comparator
Arm Description
Procedure: Sinus lift and long implant performing sinus lift surgical procedure with simultaneous placement of limplants to support screw-retained prosthesis Device: Metal ceramic prosthesis on long implants porcelain fused to metal fixed screw-retained prosthesis supported by implants
Intervention Type
Procedure
Intervention Name(s)
Closed sinus lift procedure
Other Intervention Name(s)
Minimal invasive sinus lift
Intervention Description
The closed sinus lift is the elevation of the sinus membrane through the osteotomy
Intervention Type
Device
Intervention Name(s)
Crestal sinus lift
Other Intervention Name(s)
Minimal invasive sinus lift
Intervention Description
The crestal approach is the elevation of the sinus membrane by osteotomes, piezosurgery, or Densah burs.
Primary Outcome Measure Information:
Title
Plaque index evaluation
Description
measuring plaque accumulation around implants using scores Plaque will be assessed according to modified plaque index describe as follows: score 0; no plaque detected, score 1; plaque recognized only by running a probe across a smooth marginal surface of the implant, score 2; plaque can be seen by naked eye, and score 3; abundance of soft mater.
Time Frame
one year
Title
Gingival index evaluation
Description
measuring inflammation around implants using scores Modified index will be recorded as follows: score 0; normal , score 1; mild inflammation (slight change in color & slight edema), but no bleeding on probing, score 2; moderate inflammation (redness & edema), and bleeding on probing, and score 3; sever inflammation (marked redness, edema & ulceration) with tendency to spontaneous bleeding.
Time Frame
one year
Title
Probing depth evaluation
Description
measuring per-implant probing depth in mm. Using a calibrated plastic periodontal probe, the distance between marginal border of the and the tip of the probe was measured in mm and considered as pocket depth.
Time Frame
one year
Title
Implant stability evaluation
Description
measuring the mobility of the implants using resonance frequency analysis Implant stability quotient) The resonance frequencies will be measured with the osstell® device (implant stability meter) and will be expressed with measurement scale (implant stability quotient).
Time Frame
one year
Title
Radio graphic evaluation
Description
measuring bone loss around implants in mm Radio-graphs were taken using direct digital imaging system - Marginal alveolar bone changes (vertical and horizontal bone loss) were measured at medial and distal surface of each implant in mm.
Time Frame
one year
Title
Patient satisfaction
Description
Patient satisfaction using questionnaire (visual analogue scale) Patient satisfaction was evaluated using a questionnaire based on visual analog scale . Patients were asked to mark their answer (amount of satisfaction) on a 100-mm line (with zero refers to not satisfied at all and 100 refers to completely satisfied). The mean of the answers (length of the lines from zero to the marks in mm) for each question. 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 was subjected to statistical analysis
Time Frame
one year
Secondary Outcome Measure Information:
Title
Prosthetic complication
Description
incidence of prosthetic aspects and maintenance requirements
Time Frame
one year
Title
Muscle activity
Description
Muscle activity measure muscles activity in amplitude using electromyographs
Time Frame
one year
Title
maximum bite force
Description
measuring maximum bite force in newton using bite force transducers
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: The patients will be selected according to the following: They have atrophied unilateral distal extension maxillary ridge and remaining alveolar bone height 6- 8mm as verified by preoperative CBCT, 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
Facility Information:
Facility Name
Faculty of Dentistry, Mansoura University Mansoura, Eldakahlia, Egypt, 35516
City
Mansoura
ZIP/Postal Code
02050
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Management of Distally Extension Maxillary Atrophied Ridge With Two Different Minimal Invasive Treatment Modalities

We'll reach out to this number within 24 hrs