Comparison of Short Implant Assisted Mandibular Overdenture Designs

NCT04582162 | Completed

• 1 other identifier: short implant in overdentures
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Mandibular Bone Resorption

Keywords

short implants

Outcome Measures

Primary Outcomes (5)

• 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.

  up to 12 months

• 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.

  up to 12 months

• 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.

  up to 12 months

• 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.

  up to 12 months

• 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.

  up to 12 months

Study Arms (2)

Unsplinted implants

EXPERIMENTAL

Other: Unsplinted implants

Splinted implants

ACTIVE COMPARATOR

Other: Splinted implants

Interventions

Unsplinted implants OTHER

Patients received ball abutments on each implant without splinting for retaining an implant retained mandibular overdenture.

Unsplinted implants

Splinted implants OTHER

Patients had their implants splinted using Rhein bars with ball extension for retaining an implant retained mandibular overdenture.

Splinted implants

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Nourhan M.Aly: lead
• Alexandria University: collaborator

Study Sites (1)

Faculty of Dentistry, Alexandria University

Alexandria, 21512, Egypt

Location

Related Publications (7)

• 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.

  PMID: 18724851 BACKGROUND

• 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.

  PMID: 12378486 BACKGROUND

• 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.

  PMID: 16392351 BACKGROUND

• 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.

  PMID: 22034499 BACKGROUND

• 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.

  PMID: 19033026 BACKGROUND

• 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.

  PMID: 12969363 BACKGROUND

• 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.

  PMID: 10759117 BACKGROUND

Study Officials

• Ahmed Weheda, M.Sc

  Faculty of Dentistry, Alexandria University, Egypt

  PRINCIPAL INVESTIGATOR

• Ahmed A Abdelhakim, PhD

  Faculty of Dentistry, Alexandria University, Egypt

  STUDY CHAIR

• Magued H Fahmy, PhD

  Faculty of Dentistry, Alexandria University, Egypt

  STUDY CHAIR

• Nermeen A Rady, PhD

  Faculty of Dentistry, Alexandria University, Egypt

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Lecturer of Dental Public Health

Study Record Dates

• First Submitted: October 4, 2020
• First Posted: October 9, 2020
• Study Start: December 5, 2018
• Primary Completion: September 5, 2020
• Study Completion: September 30, 2020
• Last Updated: December 4, 2023

Record last verified: 2023-12

Locations

EG (1)