protocol for a randomized controlled trial.

Not Applicable

• Conditions: Oral Health; Edentulism

• Registration Number: PACTR201803003085193
• Lead Sponsor: prosthodontic department

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-02-12
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Other
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Completely edentulous male or female patients between the ages of 50 to 69.
-No contraindications for implantation.
-Each patient has to perform both a random blood sugar and Glycosylated Hemoglobin analysis. Patients with a Glycosylated hemoglobin test HbA1c up to 8% and a normal blood sugar level (79 to 110) or controlled diabetes (90-130 fasting according to American Association of Diabetes) will be included.
-Sufficient bone width (¿ 5 mm) in the anterior region to place an implant. It could be either normally present or achieved by bone plateauing. This will be confirmed by cone beam computed tomographic (CBCT) scans.
-Residual bone height is 11-20 and 13 mm as the lowest vertical height of the mandible and the lowest vertical bone height in the midline of the mandible, respectively (Class II or III according to McGarry et al. 1999.
-Patients seeking to install a single median implant in the mandible and for whom new dentures will be constructed.
-Patients, who are dissatisfied with the retention and stability of their technically satisfactory mandibular dentures.
-Patients, who already have existing maxillary and mandibular complete dentures, and after examination of the mandibular dentures, it is found that there are technical problems with regard to denture design and/or occlusion; then new maxillary and mandibular dentures will be fabricated.
-All patients should have adapted to their dentures for at least six weeks before being included in the trial.
-Provide a written consent to participate in the trial, and this will be done before the scheduled date for implant installation.

Exclusion Criteria

-Patients with a systemic or local contra-indication for implant placement.
-Satisfied patients with the retention of their mandibular denture as well as unsatisfied patients with their maxillary denture.
-Patient with a mandibular denture height less than 6 mm between the base of the denture and the incisal edge of the central incisors (this was measured by a caliper).
-Patients who are classified as Class I, or IV according to McGarry et al. 1999.
-Incompliant and not cooperative patients.
-Patients with an implant stability less than 60 ISQ (this is not an exclusion criteria in this phase, this would be considered during implant installation).

Study & Design

• Study Type: Interventional
• Study Design: Not specified