Connective Tissue Graft Versus a Porcine-derived Membrane (Mucoderm) After Immediate Placement

January 31, 2021 updated by: Vilniaus Implantologijos Centro (VIC) Klinika

The Influence of a Connective Tissue Graft Versus a Porcine-derived Membrane (Mucoderm) on the Aesthetic Outcome After Immediate Placement and Loading of a Tapered Dental Implant in the Anterior Maxilla. A Randomized Controlled Clinical Trial.

Esthetic outcome of immediate implant placement in fresh extraction sockets remains one of the biggest challenges in implant dentistry. Recently a method to preserve the peri-implant tissues was introduced using provisional restoration, allogenic bone and soft tissue thickening. However, the evidence that this immediate provisialisation with soft tissue grafting using different grafting materials results in constantly high Pink Esthetic scores, especially compared to the delayed loading approach is still lacking.

The aim of this clinical trial is to assess the esthetic outcome of immediate temporization of immediately placed and loaded tapered implants in fresh extraction sockets with bone and soft tissue augmentation, using either a connective tissue graft (CTG) or a porcine-derived membrane (Mucoderm) in maxillary anterior sites.

The secondary objectives are to investigate the influence of immediate loading on the success rate of tapered implants and crestal bone levels.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Lithuania
      • Vilnius, Lithuania, 10205
        • VIC Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Males and females of at least 18 years of age
  2. 1 implant per patient
  3. Subject must have voluntarily signed the informed consent before any study related action, are willing and able to attend scheduled follow-up visits, and agree that the pseudonymized data will be collected and analyzed
  4. Anterior single teeth (canines and incisors) in both jaws
  5. Class I extraction socket (intact buccal wall) or Class II (1/3 of buccal wall)
  6. No recession of gingival contour of tooth to be extracted
  7. No periodontal bone loss of neighboring anterior teeth
  8. No implants in neighboring teeth
  9. Atraumatic extraction of the tooth with intact socket walls remaining

Exclusion Criteria:

  1. Deep bite (severe II class)
  2. Heavy smokers (more than 10 cigarettes/day)
  3. Systemic disease (diabetes, osteoporosis)
  4. Primary stability after implant placement not achieved
  5. Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test group
Immediate implant placement and temporization of tapered implants after tooth extraction with buccal augmentation using allogenic bone and porcine-derived membrane.
Device: Dental implant placement, bone and soft tissue augmentation on buccal site
  1. Atraumatic extraction
  2. Palatinal positioning of tapered implant (BLX) 3.75mm diameter
  3. 3-4 mm below vestibular gingival line or 1 mm below bone crest
  4. Implant placement
  5. Allogenic bone packing of the "jumping distance" and soft tissue grafting
  6. Connective tissue graft (CTG) or porcine-derived membrane
  7. Provisional restoration out of occlusion and mandibular movements
  8. X-ray
Experimental: Control group
Immediate implant placement and temporization of tapered implants after tooth extraction with buccal augmentation using allogenic bone and connective tissue grafting (CTG).
Device: Dental implant placement, bone and soft tissue augmentation on buccal site
  1. Atraumatic extraction
  2. Palatinal positioning of tapered implant (BLX) 3.75mm diameter
  3. 3-4 mm below vestibular gingival line or 1 mm below bone crest
  4. Implant placement
  5. Allogenic bone packing of the "jumping distance" and soft tissue grafting
  6. Connective tissue graft (CTG) or porcine-derived membrane
  7. Provisional restoration out of occlusion and mandibular movements
  8. X-ray

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aesthetic evaluation
Time Frame: Change from baseline, 1 year, 5 and 10 years after prosthetic delivery
Pink esthetic score (PES) according to Fürhauser et al. 2005 Seven variables will be evaluated: mesial papilla, distal papilla, soft-tissue level, soft-tissue contour, alveolar process deficiency, soft-tissue color and texture. Using a 0-1-2 scoring system, 0 being the lowest, 2 being the highest value, the maximum achievable PES is 14. For the PES assessment, frontal photographs will be taken using a digital camera with a flash strobe mounted on a tripod (Canon 350d, 3456×2304 pixel resolution). PES will be assessed at baseline (Final Prosthesis), 3- and 12-month visit.
Change from baseline, 1 year, 5 and 10 years after prosthetic delivery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recession of gingiva (REC)
Time Frame: Change from baseline, 1 year, 5 and 10 years after prosthetic delivery
Position of the gingival/mucosal margin - recorded with a periodontal probe from the incisal edge to the margin at the zenith.
Change from baseline, 1 year, 5 and 10 years after prosthetic delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vilniaus Implantologijos Centro (VIC) Klinika

Collaborators

Straumann Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2017

Primary Completion (Actual)

December 31, 2019

Study Completion (Anticipated)

February 10, 2031

Study Registration Dates

First Submitted

January 15, 2021

First Submitted That Met QC Criteria

January 31, 2021

First Posted (Actual)

February 4, 2021

Study Record Updates

Last Update Posted (Actual)

February 4, 2021

Last Update Submitted That Met QC Criteria

January 31, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IIS1418

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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