Human clinical trial involving dental implants placed in the smile zone of the mouth comparing the aesthetics of the gum tissue around the implants restored with crowns using 2 different approaches.

Not Applicable

• Conditions: Missing teeth in the smile zone of the mouth; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12613001034729
• Lead Sponsor: Dr Anand Patel

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-09-17
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Inclusion criteria
Healthy males and females over the age of 18 will:
*Be informed of the nature of the study and will be given a written informed consent,
*Have no significant diseases/ medical conditions during screening,
*Be on no regular medical treatment or on medication affecting bone physiology,
*Be able to communicate effectively with study personnel,
&Have a missing tooth on each side of the one jaw in the antero lateral segments,
*Have adequate bone levels (judged by radiographic assessment) to afford an implant based therapy to replace these missing teeth, and
*Be keen and motivated to have these missing teeth replaced.

Exclusion Criteria

Exclusion criteria
*Any disease or condition which might compromise the haematopoietic, renal, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.
*History of allergic conditions – asthma, urticaria, eczema.
*History of autoimmune disorders – lupus erythematosis (SLE).
*History of psychiatric disorders.
*Smokers
*Pregnancy or not using appropriate means on contraception.
*Use of any recreational drugs or a history of drug addiction.
*Bisphosphonate therapy.
*Patients with uncontrolled dental diseases like caries and periodontitis.
*Poor Oral hygiene
*Ridge deficiencies that warrant bone augmentation procedure either at or prior to implant placement. The minimum ridge dimension of 7mm width as measured by a ridge caliper or using a cone beam CT scan will be applied as a preliminary criteria. ( Should the subject need an augmentation for implants to be placed and should he/ she meet no other exclusion criteria but meet all inclusion criteria , he/ she can be reassessed for inclusion 6 months after an augmentation procedure ( at patients cost ) ).
*Patients lack of availability as and when recalled or attitudes / expectations gauged during interview process will be assessed for eligibility for the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified