Oral Health Related Quality of Life and Peri-implant Condition in Single Implant Overdenture

Quality of Life Clinical Trial

Official title:

Oral Health Related Quality of Life and Peri-implant Condition in Single Implant Mandibular Overdenture Retained by CM LOC Versus Ball Attachment: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02861313
• Other study ID #: CEBD-CU-2016-07-175
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: April 2018

Study information

• Verified date: September 2019
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Comparing the quality of life and periimplant condition around a single implant retained mandibular overdenture in two groups one will have a ball attachment and the other is having a (CM-LOC) one.

Description:

Single implant retained mandibular overdenture is considered an economic and simple treatment modality for edentulous subjects. Resin matrix (CM LOC) is one of the low profile attachments which represent a promising retention values with subsequent improvement in chewing ability and in turns enhance patient quality of life.Oral health impact profile for edentulous patient (OHIP-EDENT) is more specific to edentulous subjects.

Peri-implant soft tissue health (bleeding, inflammation, etc...) is a valuable marker to implant success. The study will record different attachment influenced-tissue response and its relation to implant success and oral health related quality of life (OHRQOL)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: April 2018
• Est. primary completion date: October 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 69 Years

Eligibility

Inclusion Criteria:

• 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 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.

Related Conditions & MeSH terms

• Implant
• Quality of Life

Intervention

Device:
• CM LOC attachment
CM LOC attachment
• ball attachment
Ball attachment

Locations

Country	Name	City	State
Egypt	Removable Prosthodontic Department, Faculty of Oral and Dental Medicine - Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in oral health related quality of life using (oral health impact profile edentulous) questionnaire (OHIP-EDENT)	likert scale from 0-4	from baseline up to 5 years
Secondary	change in modified gingival index	score measurement from 0-4 where 0 is no inflammation and 4 is sever inflammation	from baseline up to 5 years
Secondary	change in plaque index	score measurement from 0-3 where 0 denotes absence of plaque, 3 abundant plaque	from baseline up to 5 years
Secondary	modified bleeding index	score measurement from 0-3 where 0 denotes no bleeding, 3 profuse bleeding	from baseline up to 5 years