Clinical trial NCT02881905: PeriImplant Soft Tissue and Marginal Bone Loss of Single Implant Mandibular Overdenture
Official title: Peri-Implant Soft Tissue Health and Marginal Bone Loss of Single Implant Mandibular Overdenture Retained by CM LOC Versus Ball Attachment: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Complete Edentulism
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: University of Kiel
First posted: 2016-08-29
Enrollment: 36
Sex: ALL
Minimum age (years): 50
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There is a significant difference between CM LOC and ball attachment, when considering the peri-implant soft tissue health and marginal bone loss. The primary and secondary objectives are to determine if CM LOC attachment improves the peri-implant soft tissue response and decreases the marginal bone loss around implant when compared to conventional ball attachment

Detailed description: Ball attachments are very commonly used because they are solitary, simple, easier to use and less technique sensitive if compared to bar attachments. However, ball attachment require a prosthetic space of 12 mm and could show tremendous wear if implants were mal-aligned. CM LOC attachment is newly introduced into market with very good expectations regarding its properties and effect on the periimplant soft tissue. CM LOC attachment, which combes titanium patrix and resin matrix made from polyetherketoneketone (PEKK), is a very promising material regarding the wear and the prosthesis retention it provides, even with mal-aligned implants. However, the clinical performance of this attachment was not tested yet. Therefore, in this randomized controlled trial it was decided to compare between CM LOC and the commonly used ball attachment regarding the soft tissue health and marginal bone loss.

Eligibility criteria: 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 diabetic patients (90-130 fasting according to American Association of Diabetes) will be included.
* Sufficient bone width (≥ 6 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 ranging from 11-20 mm with the lowest vertical height in the midline of the mandible not less than 13 mm (Class II or III according to McGarry et al\[16\] 1999). This will be confirmed by the CBCT.
* Patients seeking to install a single symphyseal implant and for whom new dentures will be constructed.
* Patients, who are dissatisfied with the retention and stability of their technically satisfactory 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.
* Patients providing written informed consents 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 (as measured by a caliper) or with 12 mm crown height space as measured by a ruler from the incisal edge till the crest of the ridge. This will be done from a putty index of the diagnostic set up.
* Incompliant and not cooperative patients.
* Patients smoking more than 10 cigarettes per day.

Primary outcomes:
measure: Soft tissue reaction :Presence of mucositis
timeFrame: [from baseline up to 1 year]
Secondary outcomes:
measure: Modified gingival Index
timeFrame: from baseline up to 1 year. score measurement from 0-4 where 0 is no inflammation and 4 is severe inflammation
measure: Modified Plaque Index
timeFrame: from baseline upto 1 year. score measurement from 0-3 where 0 denotes no plaque present and 3 denotes abundant plaque
measure: Modified Bleeding Index
timeFrame: from baseline upto 1 year. score from 0-3 where 0 denotes no bleeding and 3 denotes profound bleeding
measure: marginal bone loss
timeFrame: from baseline up to 1 year
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Outpatient Clinic-Prosthodontic Department-Faculty of Dentistry-Cairo University
Study officials:
affiliation: prosthodontic department-faculty of dentistry-cairo university
name: nouran abdelnaby, phd
role: STUDY_DIRECTOR
References: