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Comparison of Short Implant Assisted Mandibular Overdenture Designs

Primary Purpose

Mandibular Bone Resorption

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Unsplinted implants
Splinted implants
Sponsored by
Nourhan M.Aly
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mandibular Bone Resorption focused on measuring short implants

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Completely edentulous patients.
  • Mandibular ridge should be a maximum of 10mm height and with a minimum width of 8 mm to insert implants without grafting procedures.
  • Patients free from systemic diseases that contradict the use of dental implants.
  • Patients with class I ridge relation.
  • Patients with adequate zone of keratinized mucosa.
  • Patients with U-shaped or square shaped arches

Exclusion Criteria:

  • Non-compliant patients based on history.
  • Heavy smokers.
  • Senile patients (over 75 years) with impaired neuromuscular control.

Sites / Locations

  • Faculty of Dentistry, Alexandria University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Unsplinted implants

Splinted implants

Arm Description

Outcomes

Primary Outcome Measures

Implant stability
Stability was assessed using resonance frequency analysis measured with the Osstell device instrument. The Osstell unit records a numeric value of 1-100 which is referred to as the implant stability quotient (ISQ). The measurements were performed and 3 mean of three readings were recorded in each evaluation period.
Peri-implant probing depth
Peri-implant probing depth refers to the distance between the gingival margin and the most apically probable portion in millimeters (mm). The peri-implant probing depth was measured using a graduated plastic periodontal probe. The probe was held parallel to the long axis of the implant and introduced to the peri-implant sulcus until slight resistance was felt. Measurements were made at four sites around each implant; buccal, lingual, mesial and distal. Probing depth of 1 mm or less was recorded as "1mm", and those exceeding 1 mm but less than 2 mm were recorded as "2mm" and so forth. The mean records for each implant were then calculated.
Clinical attachment loss
It is the distance from the junction implant/abutment to the most apically probable portion, in millimeters. Assessment of the clinical attachment level was performed simultaneously while measuring the peri-implant probing depth.
Gingival inflammation (Modified gingival index)
The peri-implant mucosal tissues around the implants were assessed using Apse's modification of Löe and Silness index. The criteria for assessment were: 0 =Normal mucosa, 1 =Mild inflammation, slight change in colour and texture, slight oedema and no bleeding on probing, 2 =Mild inflammation, redness, in all portions of gingival margin, 3 =Moderate inflammation, 4 =Severe inflammation. The gingival index was assessed at 4 sites around each implant (buccal, lingual, mesial and distal) the sum gingival index score was calculated from all these surfaces and then divided by 4 to obtain the gingival index for each implant. Indices of the three implants were added to each other, and then divided by 3 to get the mean gingival index for each case. A score from 0.1-1.0 reflects mild inflammation; 1.1-2.0 reflects moderate inflammation from, and 2.1-3.0 signifies severe inflammation.
Crestal bone loss
Mesial and Distal crestal bone loss were evaluated using digital periapical x-rays. In order to standardize the cones' and sensors' position and angulation, a film positioning system was used along with a customized silicone bite.

Secondary Outcome Measures

Full Information

First Posted
October 4, 2020
Last Updated
October 4, 2020
Sponsor
Nourhan M.Aly
Collaborators
Alexandria University
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1. Study Identification

Unique Protocol Identification Number
NCT04582162
Brief Title
Comparison of Short Implant Assisted Mandibular Overdenture Designs
Official Title
Comparison of Short Implant Assisted Mandibular Overdenture Designs (A Randomized Clinical Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
December 5, 2018 (Actual)
Primary Completion Date
September 5, 2020 (Actual)
Study Completion Date
September 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Nourhan M.Aly
Collaborators
Alexandria 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
The aim of the study was to clinically and radiographically evaluate and compare the use of unsplinted and splinted short implants with ball abutments to support mandibular overdentures in cases with severe mandibular ridge resorption.
Detailed Description
Twelve patients from the Prosthodontics Department in the Faculty of Dentistry, Alexandria University participated in the study. Patients were divided into 2 groups. The test group received 4 short implants with ball abutments for the construction of a mandibular assisted overdenture, while the control group received 4 short implants splinted using a bar with a ball attachment for retaining a mandibular overdenture.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mandibular Bone Resorption
Keywords
short implants

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Unsplinted implants
Arm Type
Experimental
Arm Title
Splinted implants
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Unsplinted implants
Intervention Description
Patients received ball abutments on each implant without splinting for retaining an implant retained mandibular overdenture.
Intervention Type
Other
Intervention Name(s)
Splinted implants
Intervention Description
Patients had their implants splinted using Rhein bars with ball extension for retaining an implant retained mandibular overdenture.
Primary Outcome Measure Information:
Title
Implant stability
Description
Stability was assessed using resonance frequency analysis measured with the Osstell device instrument. The Osstell unit records a numeric value of 1-100 which is referred to as the implant stability quotient (ISQ). The measurements were performed and 3 mean of three readings were recorded in each evaluation period.
Time Frame
up to 12 months
Title
Peri-implant probing depth
Description
Peri-implant probing depth refers to the distance between the gingival margin and the most apically probable portion in millimeters (mm). The peri-implant probing depth was measured using a graduated plastic periodontal probe. The probe was held parallel to the long axis of the implant and introduced to the peri-implant sulcus until slight resistance was felt. Measurements were made at four sites around each implant; buccal, lingual, mesial and distal. Probing depth of 1 mm or less was recorded as "1mm", and those exceeding 1 mm but less than 2 mm were recorded as "2mm" and so forth. The mean records for each implant were then calculated.
Time Frame
up to 12 months
Title
Clinical attachment loss
Description
It is the distance from the junction implant/abutment to the most apically probable portion, in millimeters. Assessment of the clinical attachment level was performed simultaneously while measuring the peri-implant probing depth.
Time Frame
up to 12 months
Title
Gingival inflammation (Modified gingival index)
Description
The peri-implant mucosal tissues around the implants were assessed using Apse's modification of Löe and Silness index. The criteria for assessment were: 0 =Normal mucosa, 1 =Mild inflammation, slight change in colour and texture, slight oedema and no bleeding on probing, 2 =Mild inflammation, redness, in all portions of gingival margin, 3 =Moderate inflammation, 4 =Severe inflammation. The gingival index was assessed at 4 sites around each implant (buccal, lingual, mesial and distal) the sum gingival index score was calculated from all these surfaces and then divided by 4 to obtain the gingival index for each implant. Indices of the three implants were added to each other, and then divided by 3 to get the mean gingival index for each case. A score from 0.1-1.0 reflects mild inflammation; 1.1-2.0 reflects moderate inflammation from, and 2.1-3.0 signifies severe inflammation.
Time Frame
up to 12 months
Title
Crestal bone loss
Description
Mesial and Distal crestal bone loss were evaluated using digital periapical x-rays. In order to standardize the cones' and sensors' position and angulation, a film positioning system was used along with a customized silicone bite.
Time Frame
up to 12 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Completely edentulous patients. Mandibular ridge should be a maximum of 10mm height and with a minimum width of 8 mm to insert implants without grafting procedures. Patients free from systemic diseases that contradict the use of dental implants. Patients with class I ridge relation. Patients with adequate zone of keratinized mucosa. Patients with U-shaped or square shaped arches Exclusion Criteria: Non-compliant patients based on history. Heavy smokers. Senile patients (over 75 years) with impaired neuromuscular control.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Weheda, M.Sc
Organizational Affiliation
Faculty of Dentistry, Alexandria University, Egypt
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ahmed A Abdelhakim, PhD
Organizational Affiliation
Faculty of Dentistry, Alexandria University, Egypt
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Magued H Fahmy, PhD
Organizational Affiliation
Faculty of Dentistry, Alexandria University, Egypt
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Nermeen A Rady, PhD
Organizational Affiliation
Faculty of Dentistry, Alexandria University, Egypt
Official's Role
Study Chair
Facility Information:
Facility Name
Faculty of Dentistry, Alexandria University
City
Alexandria
ZIP/Postal Code
21512
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
18724851
Citation
Rocchietta I, Fontana F, Simion M. Clinical outcomes of vertical bone augmentation to enable dental implant placement: a systematic review. J Clin Periodontol. 2008 Sep;35(8 Suppl):203-15. doi: 10.1111/j.1600-051X.2008.01271.x.
Results Reference
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PubMed Identifier
12378486
Citation
Bell RB, Blakey GH, White RP, Hillebrand DG, Molina A. Staged reconstruction of the severely atrophic mandible with autogenous bone graft and endosteal implants. J Oral Maxillofac Surg. 2002 Oct;60(10):1135-41. doi: 10.1053/joms.2002.34986.
Results Reference
background
PubMed Identifier
16392351
Citation
Gentile MA, Chuang SK, Dodson TB. Survival estimates and risk factors for failure with 6 x 5.7-mm implants. Int J Oral Maxillofac Implants. 2005 Nov-Dec;20(6):930-7.
Results Reference
background
PubMed Identifier
22034499
Citation
Annibali S, Cristalli MP, Dell'Aquila D, Bignozzi I, La Monaca G, Pilloni A. Short dental implants: a systematic review. J Dent Res. 2012 Jan;91(1):25-32. doi: 10.1177/0022034511425675. Epub 2011 Oct 27.
Results Reference
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PubMed Identifier
19033026
Citation
Baggi L, Cappelloni I, Di Girolamo M, Maceri F, Vairo G. The influence of implant diameter and length on stress distribution of osseointegrated implants related to crestal bone geometry: a three-dimensional finite element analysis. J Prosthet Dent. 2008 Dec;100(6):422-31. doi: 10.1016/S0022-3913(08)60259-0.
Results Reference
background
PubMed Identifier
12969363
Citation
Bernard JP, Szmukler-Moncler S, Pessotto S, Vazquez L, Belser UC. The anchorage of Branemark and ITI implants of different lengths. I. An experimental study in the canine mandible. Clin Oral Implants Res. 2003 Oct;14(5):593-600. doi: 10.1034/j.1600-0501.2003.120908.x.
Results Reference
background
PubMed Identifier
10759117
Citation
Stellingsma C, Meijer HJ, Raghoebar GM. Use of short endosseous implants and an overdenture in the extremely resorbed mandible: a five-year retrospective study. J Oral Maxillofac Surg. 2000 Apr;58(4):382-7; discussion 387-8. doi: 10.1016/s0278-2391(00)90917-0.
Results Reference
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Comparison of Short Implant Assisted Mandibular Overdenture Designs

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