The Influence of a New Implant Neck Configuration on Hard and Soft Tissue Healing

The Influence of a New Implant Neck Configuration on Hard and Soft Tissue Healing. A Randomized Controlled Clinical Trial

Title: Randomized Controlled Clinical Trial comparing two dental implants with different neck configurations.

Objective: To evaluate the changes in peri-implant soft tissues and marginal bone level when using a one-piece implant with a widening transgingival machined collar and a one-piece implant with a tapering transgingival machined collar.

Design: The study will be a prospective parallel randomized clinical trial with a 12 month follow up conducted in 5 private dental practices. A total of 50 patients meeting the inclusion criteria will be randomized in one of the two groups to receive 1 single implant placed in healed ridges. Radiographic and clinical measurements will be taken post-insertion, baseline (post-loading) 6 and 12 months after loading.

Study Hypothesis: The hypothesis of this study is that there will be no differences in the preservation of the peri-implant marginal bone level and peri-implant soft tissues between the two implant neck designs.

Study Overview

• Status: Unknown
• Conditions: Implant Geometry, Osseointegration, Soft Tissue Volume, Marginal Bone Levels, Soft Tissue Recession, Volumetric Analysis
• Intervention / Treatment: Procedure: dental implant placement

Detailed Description

The study will be a prospective parallel randomized clinical trial (RCT) of approximately 20 months of duration, in which each patient will receive 1 implants placed in the posterior mandible. If the patients fulfill the inclusion criteria after implant site preparation, they will be randomized to either receive an implant with a one-piece tapering neck configuration (P) or with a widening neck configuration (TL).

52 patients, male or female, aged 18 or older, who are missing one tooth in the posterior mandible (positions 4-6).

A randomization list will determine which implant type has to be inserted. This randomization list will be generated by an independent investigator.

Patients will be recruited by the investigator consecutively. Prior to implant site preparation, the clinician will determine if the patient still meets the inclusion criteria at surgery in particular if the bone quantity is sufficient. Patients who do not meet the inclusion criteria will be excluded from the study and will therefore not be randomized. The patients will be randomized to receive P implant or TL implant.

For both groups, impression will be taken 8 weeks post insertion. Details with regard to the prosthetic procedures and materials used for the restoration of the implants will be provided in a separate section of this protocol.

Standardized peri-apical radiographs will be taken before and after prosthesis placement to document the crestal bone level at the day of loading.

Standardized photographs will be taken to measure the soft tissue at the time of loading.

The thickness of the soft tissue will be measured 2 mm apical to the gingival margin with a needle.

Routine controls are due at 6 and 12 months post loading. Peri-apical radiographs will be taken after implant placement, before/after loading and at 12 months post loading. Final impressions will be taken at 12 months post loading to evaluate volumetric changes.

• Study Type: Interventional
• Enrollment (Anticipated): 52
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Beatriz Sanchez, DDS; Phone Number: +34659782398; Email: beatrizsanchez@periocentrum.com
• Study Contact Backup: Name: Rocío Fernandez; Phone Number: +34662137520; Email: rociofernandez@periocentrum.com

Study Locations

• Spain
  • Madrid, Spain, 28020
    • Recruiting
    • PerioCentrum Madrid
    • Contact: Beatriz Sanchez, DDS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female ≥18 years old
• Each patient will have one missing tooth in the posterior mandible (positions 4-6). There must be a natural tooth mesially and distally to the implant site. Free end situation are not allowed.
• Adequate bone quality and quantity at the implant site to permit the insertion of a SWEDEN AND MARTINA® Prama Implant in the diameter of 4.25 mm and in the length of 8.5 mm, 10 mm or a Straumann Tissue Level in the diameter of 4.1 mm and in the length of 8 mm or 10mm.
• Opposing dentition must be natural teeth or teeth/implant supported fixed restoration(s).
• Patient has been informed of the follow-up visits and is willing to return to the clinical center for these follow-up visit.

Exclusion Criteria:

• These exclusion criteria might be systemic or local. In addition to the general contra-indication for dental implants the following exclusion criteria will be observed:

Systemic exclusion criteria:

• Medical conditions requiring prolonged use of steroids and/or with medications that can interfere with bone metabolism
• History of leukocyte dysfunction and deficiencies
• History of neoplasic disease requiring the use of radiation or chemotherapy
• Patients with history of renal failure
• Patients with metabolic bone disorders such as osteoporosis
• History of uncontrolled endocrine disorders
• Physical handicaps that would interfere with the ability to perform adequate oral hygiene
• Use of any investigational drug or device within the 30 day period immediately prior to implant surgery on study day 0
• Alcoholism or drug abuse
• History of immunodeficiency syndromes
• Patients who smoke >20 cigarettes per day or cigar equivalents.
• 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, unreliability

Local exclusion criteria:

• Any bone augmentation on the implant site which was performed in the previous 3 months
• Local inflammation, including untreated periodontitis
• Mucosal diseases such as erosive lichen planus
• History of local irradiation therapy
• Presence of osseous lesions
• Unhealed extraction sites (less than 6 weeks post extraction of teeth in intended sites)
• Severe bruxing or clenching habits
• Persistent intraoral infection

Exclusion criteria at surgery:

• Lack of primary stability of implant.
• Presence of vertical dehiscence
• Unable to place the implant according to the prosthetic requirements. In any of these instances the patient will not be included in the study and a new patient will be recruited and randomized.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: convergent neck; Group A Sweden & Martina Prama (P). Transgingival tapering machined collar, 2.8 mm in height.	Procedure: dental implant placement; Implants will be placed according to the manufacturer recommendations. Implants will be placed at 1.5 to 2.0 mm from the adjacent natural tooth. However, these distances will be directed by the prosthetic crown needed and they will be recorded in the CRF.
Sham Comparator: divergent neck; Group B Straumann Tissue Level (TL). Transgingival widening polished collar, 1.8 mm in height.	Procedure: dental implant placement; Implants will be placed according to the manufacturer recommendations. Implants will be placed at 1.5 to 2.0 mm from the adjacent natural tooth. However, these distances will be directed by the prosthetic crown needed and they will be recorded in the CRF.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
soft tissue volumetric changes	soft tissue volumetric changes between baseline and one year	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
marginal bone levels	marginal bone levels between baseline and at one year	1 year
implant survival rate	no mobility at crown placement and at one year	1 year
probing pocket depth	probing pocket depth at crown placement and at one year	1 year
recession	recession at crown placement and at one year	1 year
keratinized mucosa	keratinized mucosa at crown placement and at one year	1 year

Collaborators and Investigators

• Sponsor: PerioCentrum Research
• Investigators: Principal Investigator: Fabio Vignoletti, PhD, PerioCentrum Research

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2019
• Primary Completion (Anticipated): November 17, 2020
• Study Completion (Anticipated): March 17, 2021

Study Registration Dates

• First Submitted: October 27, 2019
• First Submitted That Met QC Criteria: March 11, 2020
• First Posted (Actual): March 13, 2020

Study Record Updates

• Last Update Posted (Actual): March 13, 2020
• Last Update Submitted That Met QC Criteria: March 11, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: Sweden&Martina Prama project

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No