Clinical trial NCT02159183: Controlled Pilot Study to Assess Soft Tissue Reaction at the Crestal Part of a Dental Implant With ESTA Surface
Official title: A Controlled Clinical Pilot Study to Assess Soft Tissue Reaction at the Crestal Part of a Dental Implant With ESTA Surface
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Teeth Loss
Lead sponsor: Institut Straumann AG
Sponsor class: INDUSTRY
First posted: 2014-06-09
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will investigate the effect on the soft tissue that is in contact with a dental implant with a modified surface of the neck (the part of the implant that is above the bone and in contact with the soft gum tissue).

Detailed description: This is a prospective, controlled, randomised clinical pilot study with parallel groups and blinded subject.

The design has been chosen to obtain data to base a sample size calculation for future studies on by comparing the degree of mucosal inflammation of the mucosa in conjunction with the modified surface of the top of the test implant and the machined surface on the top of the control implant.

Eligibility criteria: Inclusion Criteria:

* Subjects must have voluntarily signed the informed consent form before any study related action
* Males and females must be at least 18 years of age and not more than 80 years old.
* Partially edentulous in posterior (position 3-7) maxilla or mandible with implants planned for single crowns in an area with a healed extraction socket.
* Adequate bone quality and quantity at the implant site to permit the insertion of a Straumann Soft Tissue Level implant of 4.1mm diameter without augmentation (at least 1mm bone buccally and lingually/palatal)

Exclusion Criteria:

* Oral surgery contraindicated according to the judgement of the investigator (should be explained in the CRF)
* Local inflammation, including untreated periodontitis
* Patients with inadequate oral hygiene or unmotivated for adequate home care. Full mouth plaque index \> 25% at time of surgery
* Presence of conditions requiring chronic routine prophylactic use of antibiotics (e.g., history of rheumatic heart disease, bacterial endocarditis, cardiac valvular anomalies, prosthetic joint replacements)
* Major systemic diseases
* Medical conditions requiring prolonged use of steroids
* Current pregnancy or breastfeeding women
* Physical handicaps that would interfere with the ability to perform adequate oral hygiene
* Use of any investigational drug or device within the 90 day period immediately prior to implant surgery on study day 0
* Alcoholism or chronically drug abuse
* Smokers; more than 10 cigarettes per day
* Immuno-compromised patients
* Conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, or unreliability.

Secondary Exclusion Criteria:

* GBR procedures at or adjacent to the planned study site
* Lack of primary stability of the dental implant at site of interest (e.g., rotational movement of the implant at a minimum of 15 Ncm torque at connection of the healing abutment, or tactile mobility)

Primary outcomes:
measure: Sulcus Bleeding Index (According to Mombelli et al 1987)
timeFrame: 12 months
Secondary outcomes:
measure: Sulcus Bleeding Index (According to Mombelli et al 1987)
timeFrame: 3 years
measure: Soft Tissue Healing Evaluation
timeFrame: 10 days and 12 weeks
measure: Oral Hygiene
timeFrame: Screening, 6, 12, 36 months
measure: Recession of Gingival Margin Buccally and Lingually/Palatal
timeFrame: 1 and 3 years
measure: Probing Pocket Depth (PPD)
timeFrame: 6 months, 1 and 3 years
measure: Clinical Attachment Level (CAL)
timeFrame: 6 months, 1 and 3 years
measure: Bone Crest Levels. Bone Levels (mm) - Average Over Mesial+Distal Measurements
timeFrame: 1 and 3 years
measure: Dental Implant Success and Implant Loss
timeFrame: 3 years
measure: Adverse Events
timeFrame: up to 3 years
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: University of Bern
city: Geneva
country: Switzerland
facility: University of Geneva
city: Langenthal
country: Switzerland
facility: Private Practice
city: Lausanne
country: Switzerland
facility: Ardentis Clinique Dentaire
Study officials:
affiliation: Universität Bern, Klinik für Parodontologie
name: Anton Sculean, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: