Different Treatment Modalities for Atrophied Distal Extension Maxillary Ridges
Primary Purpose
Partial Edentulism Class 1
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Long implant and partial overdentures
Sinus lift and long implant
short implant without sinus lift
Partial overdentures
Metal ceramic prosthesis on long implants
Metal ceramic prosthesis on short implants
Sponsored by
About this trial
This is an interventional treatment trial for Partial Edentulism Class 1
Eligibility Criteria
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
Sites / Locations
- Faculty of Dentistry, Mansoura University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
overdentures
sinus lift
short implants
Arm Description
implant overdentures
sinus lift and long implants and screw-retained prosthesis
short implants and screw-retained prosthesis
Outcomes
Primary Outcome Measures
Plaque index
measuring plaque accumulation around implants using scores
Gingival index
measuring gingival inflammation around implants using scores
Probing depth
measuring peri-implant probing depth in mm
implant stability
measuring the mobility of the implants using resonance frequency analysis Implant stability quotient)
Marginal bone loss
measuring crestal bone loss around implants in mm
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.
Secondary Outcome Measures
Prosthetic Aspects
measuring the incidence of prosthetic aspects and maintenance requirements
Muscle activity
measure muscles activity in amplitude using electromyographs
maximum bite force
measuring maximum bite force in newton using bite force transducers
Full Information
NCT ID
NCT05198687
First Posted
September 24, 2021
Last Updated
February 27, 2022
Sponsor
Mansoura University
1. Study Identification
Unique Protocol Identification Number
NCT05198687
Brief Title
Different Treatment Modalities for Atrophied Distal Extension Maxillary Ridges
Official Title
Comparison Between Three Different Treatment Modalities for Atrophied Distal Extension Maxillary Ridges Clinical and Radiographic Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
May 1, 2021 (Actual)
Study Completion Date
June 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
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 radiographic outcomes of three different treatment modalities for atrophied distal extension maxillary ridges these modalities include
Implant retained distal extension RPD
Sinus lift and long implant and screw-retained prosthesis
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
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.
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.
Attachment level. Distance from the junction implant/crown to the most apically probeable portion, in millimeters.
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Partial Edentulism Class 1
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
overdentures
Arm Type
Active Comparator
Arm Description
implant overdentures
Arm Title
sinus lift
Arm Type
Active Comparator
Arm Description
sinus lift and long implants and screw-retained prosthesis
Arm Title
short implants
Arm Type
Active Comparator
Arm Description
short implants and screw-retained prosthesis
Intervention Type
Procedure
Intervention Name(s)
Long implant and partial overdentures
Intervention Description
insertion of long implants anterior to the maxillary sinus to retain partial overdentures
Intervention Type
Procedure
Intervention Name(s)
Sinus lift and long implant
Intervention Description
performing sinus lift surgical procedure with simultaneous placement of long implants to support screw-retained prosthesis
Intervention Type
Procedure
Intervention Name(s)
short implant without sinus lift
Intervention Description
placement of short implants in the remaining bone above maxillary sinus to support screw-retained prosthesis without performing sinus lift
Intervention Type
Device
Intervention Name(s)
Partial overdentures
Intervention Description
Distal extension metallic partial dentures retained by attachments to the implants
Intervention Type
Device
Intervention Name(s)
Metal ceramic prosthesis on long implants
Intervention Description
porcelain fused to metal fixed screw-retained prosthesis supported by long implants
Intervention Type
Device
Intervention Name(s)
Metal ceramic prosthesis on short implants
Intervention Description
porcelain fused to metal fixed screw-retained prosthesis supported by short implants
Primary Outcome Measure Information:
Title
Plaque index
Description
measuring plaque accumulation around implants using scores
Time Frame
one year
Title
Gingival index
Description
measuring gingival inflammation around implants using scores
Time Frame
one year
Title
Probing depth
Description
measuring peri-implant probing depth in mm
Time Frame
one year
Title
implant stability
Description
measuring the mobility of the implants using resonance frequency analysis Implant stability quotient)
Time Frame
one year
Title
Marginal bone loss
Description
measuring crestal bone loss around implants in mm
Time Frame
one year
Title
Patient satisfaction using VAS questionnaire (visual analogue scale)
Description
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.
Time Frame
one year
Secondary Outcome Measure Information:
Title
Prosthetic Aspects
Description
measuring the incidence of prosthetic aspects and maintenance requirements
Time Frame
one year
Title
Muscle activity
Description
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
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Faculty of Dentistry, Mansoura University
City
Mansoura
State/Province
Eldakahlia
ZIP/Postal Code
35516
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Different Treatment Modalities for Atrophied Distal Extension Maxillary Ridges
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