Hard and Soft Tissue Maintenance Around Implants With a Sloped Configuration

NCT04712565 | Completed

• 1 other identifier: 32-514 ex 19/20
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a controlled, randomized clinical trial over about 16-months (active phase). 40 patients in need of replacement of a single tooth with a minimal crestal bone width of 4 - 5mm and suitable for simultaneous GBR (Guided Bone Regeneration) procedure as well as at least a neighboring tooth on its mesial aspect will be consecutively recruited at the Department of Dental Medicine and Oral Health Graz. Volunteers will be screened and eligible subjects will be randomized to two different groups. In group 1 implants with regular neck design (Astra Tech Implant EV C, Dentsply Implants Manufacturing GmbH, Hanau, Germany) and GBR procedure (BioOss® and BioGide®, Geistlich, Wolhusen, Schweiz) fixed with two membrane pins (Hipp Medical AG, Kolbingen, Germany) will be used; in group 2 implants with sloped marginal configuration (Astra Tech Implant Profile EV C, Dentsply Implants Manufacturing GmbH, Hanau, Germany) without bone augmentation are used. The dimension of the bony defect and amount of lingual-buccal bone height discrepancy (max. 5mm) respectively bone width will be evaluated using a 3-D volume tomography (Planmeca ProMax® 3D Max, Planmeca, Helsinki, Finland), which is needed for digital planning (Simplant Planning Software, Leuven, Belgium) of the implant position, length and diameter as well.

Conditions

Tooth Loss

Outcome Measures

Primary Outcomes (1)

• marginal bone level

  measured by single tooth X-ray

  15 months

Secondary Outcomes (6)

• implant survival rate (ISR) in percent

  15 months

• clinical parameter: Probing depth

  15 months

• clinical parameter: Bleeding on probing

  15 months

• clinical parameter: Plaque index

  15 months

• clinical parameter: Papilla index

  15 months

Study Arms (2)

Astra Tech Implant System Profile EV

EXPERIMENTAL

Implants with sloped marginal configuration without bone augmentation are used.

Device: Astra Tech Implant System Profile EV

Astra Tech Implant System EV

ACTIVE COMPARATOR

Implants with regular neck design and GBR procedure fixed with two membrane pins will be used.

Device: Astra Tech Implant System EV

Interventions

Astra Tech Implant System Profile EV DEVICE

dental implant with a sloped neck configuration

Astra Tech Implant System Profile EV

Astra Tech Implant System EV DEVICE

dental implant with a conventional neck configuration

Astra Tech Implant System EV

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written consent after clarification
• capability of giving an informed consent

You may not qualify if:

• age 18 years of age and over
• Good periodontal status: BOP \< 20%, PI \< 30%, no PD \> 4mm
• No heavy smokers (\< 10 cigarettes/day)
• At least 1 missing tooth in the premolar and molar region (in selected cases in the frontal area) either in the maxilla or in the mandible requiring implant therapy for reconstruction.
• implant site must present a buccal bone defect not extending a lingual-buccal or buccal-palatinal height discrepancy of 5mm and a sufficient bone width for simultaneously GBR procedure
• implant site must present at least a neighbouring tooth on its mesial aspect
• Insufficient bone volume for implant placement requiring a sinus floor elevation or extensive bone augmentation
• Heavy Smokers (\>10 cigarettes/day)
• Medication with a contraindication for implant therapy
• Skeletal immaturity
• Any active malignancy or ongoing treatment for malignancy
• An active infection at the operative site
• Contraindications to the class of drugs which are used at regular surgical procedures, e.g. known hypersensitivity or allergy to class of drugs or the investigational product, except penicillin-allergy
• Pregnancy
• unable or unwilling to return for follow-up visits for a period of at least 16 months

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Medical Universtiy Graz

Graz, 8010, Austria

Location

Related Publications (11)

• Araujo MG, Lindhe J. Dimensional ridge alterations following tooth extraction. An experimental study in the dog. J Clin Periodontol. 2005 Feb;32(2):212-8. doi: 10.1111/j.1600-051X.2005.00642.x.

  PMID: 15691354 BACKGROUND

• Hof M, Pommer B, Strbac GD, Suto D, Watzek G, Zechner W. Esthetic evaluation of single-tooth implants in the anterior maxilla following autologous bone augmentation. Clin Oral Implants Res. 2013 Aug;24 Suppl A100:88-93. doi: 10.1111/j.1600-0501.2011.02381.x. Epub 2011 Dec 8.

  PMID: 22150807 BACKGROUND

• Jemt T. Regeneration of gingival papillae after single-implant treatment. Int J Periodontics Restorative Dent. 1997 Aug;17(4):326-33.

  PMID: 9497723 BACKGROUND

• Lekholm U, Adell R, Lindhe J, Branemark PI, Eriksson B, Rockler B, Lindvall AM, Yoneyama T. Marginal tissue reactions at osseointegrated titanium fixtures. (II) A cross-sectional retrospective study. Int J Oral Maxillofac Surg. 1986 Feb;15(1):53-61. doi: 10.1016/s0300-9785(86)80011-4.

  PMID: 3083006 BACKGROUND

• Lorenzoni M, Pertl C, Wegscheider W, Keil C, Penkner K, Polansky R, Bratschko RO. Retrospective analysis of Frialit-2 implants in the augmented sinus. Int J Periodontics Restorative Dent. 2000 Jun;20(3):255-67.

  PMID: 11203567 BACKGROUND

• Pietrokovski J, Massler M. Alveolar ridge resorption following tooth extraction. J Prosthet Dent. 1967 Jan;17(1):21-7. doi: 10.1016/0022-3913(67)90046-7. No abstract available.

  PMID: 5224784 BACKGROUND

• Schropp L, Wenzel A, Kostopoulos L, Karring T. Bone healing and soft tissue contour changes following single-tooth extraction: a clinical and radiographic 12-month prospective study. Int J Periodontics Restorative Dent. 2003 Aug;23(4):313-23.

  PMID: 12956475 BACKGROUND

• Zuiderveld EG, Meijer HJ, Vissink A, Raghoebar GM. Outcome of Treatment with Single Implants in Preserved Versus Nonpreserved Alveolar Ridges: A 1-year Cohort Study. Int J Oral Maxillofac Implants. 2019 Nov/Dec;34(6):1457-1465. doi: 10.11607/jomi.7367.

  PMID: 31711086 BACKGROUND

• Zumstein T, Schutz S, Sahlin H, Sennerby L. Factors influencing marginal bone loss at a hydrophilic implant design placed with or without GBR procedures: A 5-year retrospective study. Clin Implant Dent Relat Res. 2019 Oct;21(5):817-826. doi: 10.1111/cid.12826. Epub 2019 Aug 21.

  PMID: 31432605 BACKGROUND

• Karasan D, Guncu MB, Ersu B, Canay S. Biomechanical Behavior of Implants with a Sloped Marginal Configuration. Int J Prosthodont. 2018 Nov/Dec;31(6):587-590. doi: 10.11607/ijp.5882.

  PMID: 30408141 RESULT

• Noelken R, Donati M, Fiorellini J, Gellrich NC, Parker W, Wada K, Berglundh T. Soft and hard tissue alterations around implants placed in an alveolar ridge with a sloped configuration. Clin Oral Implants Res. 2014 Jan;25(1):3-9. doi: 10.1111/clr.12079. Epub 2012 Dec 5.

  PMID: 23210667 RESULT

MeSH Terms

Conditions

Tooth Loss

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2021
• First Posted: January 15, 2021
• Study Start: January 14, 2021
• Primary Completion: September 11, 2025
• Study Completion: September 11, 2025
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)