Immediate Versus Late Placement

NCT04741607 | Recruiting DMC

• 1 other identifier: BC-08574
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

Patients in need of a single implant in the premaxilla will be invited to participate in this multicenter randomized controlled trial (RCT). Prior to surgery, a small-field low-dose cone beam computed tomography (CBCT) is taken to verify the integrity of the facial bone wall and an adequate amount of apical and palatal bone dimensions. Sixty patients will be randomly allocated to the test group or control group in 6 centers. Each center receives 10 sealed envelopes (5 are internally labelled with 'delayed implant placement' and 5 with 'immediate implant placement'). For each patient a digital planning is performed in implant planning software and a tooth-supported surgical guide is fabricated prior to tooth extraction. In the control group, alveolar ridge preservation is performed following tooth extraction. After a healing period of 4 months, a single implant is installed. In the test group, a single implant is installed immediately after tooth extraction and ridge preservation is performed by filling the gap between the facial bone wall and the implant surface. A provisional crown is placed at the day of implant surgery, which is replaced by a permanent one 3m later. Six months after tooth extraction and subsequent ridge preservation, the need for soft tissue grafting is assessed on the base of predetermined criteria (primary outcome measure). Soft tissue augmentation is performed by inserting a palatal connective tissue graft (CTG) into the buccal mucosa at the implant site. Secondary outcome measures include 3D hard and soft tissue changes as well as clinical, aesthetic, patient-reported and clinician-reported outcomes.

Conditions

Esthetics

Keywords

connective tissue graft; dental implant, single tooth; immediate; ridge preservation

Outcome Measures

Primary Outcomes (1)

• Need for soft tissue augmentation (true or false) as judged by a panel of clinicians

  The need for soft tissue augmentation is assessed by the 5 clinicians who have not been clinically involved. The treating clinician is excluded since he/she cannot be blinded for the treatment group. The need for soft tissue augmentation is assessed on the basis of clinical pictures, a CBCT image and STL file.

  6 months

Secondary Outcomes (15)

• Clinician-reported outcome measures

  per-op

• Changes in buccal soft tissue profile

  pre-op, 6 months, 1 year, 3 years, 5 years

• Vertical change in midfacial soft tissue level

  pre-op, 6 months, 1 year, 3 years, 5 years

• Change in width of the alveolar process

  pre-op, 1 year, 5 year

• Change in height of the alveolar process

  pre-op, 1 year, 5 year

Study Arms (2)

Control group

ACTIVE COMPARATOR

Delayed implant placement

Device: Implant placement (BLX implant system, Straumann, Basel, Switzerland); Procedure: Ridge preservation (Bio-Oss Collagen 250 mg, Geistlich Pharma AG, Wolhusen, Switserland); Procedure: Socket seal (Mucograft Seal, Geistlich Pharma AG, Wolhusen, Switserland)

Test group

EXPERIMENTAL

Immediate implant placement

Device: Implant placement (BLX implant system, Straumann, Basel, Switzerland); Procedure: Ridge preservation (Bio-Oss Collagen 250 mg, Geistlich Pharma AG, Wolhusen, Switserland)

Interventions

Implant placement (BLX implant system, Straumann, Basel, Switzerland) DEVICE

Implants are placed after a healing period of 4 months (delayed implant placement, control group) or immediately after tooth extraction and ridge preservation (immediate implant placement, test group).

Control group; Test group

Ridge preservation (Bio-Oss Collagen 250 mg, Geistlich Pharma AG, Wolhusen, Switserland) PROCEDURE

Ridge preservation is performed by inserting a collagen-enriched DBBM (Bio-Oss Collagen 250 mg, Geistlich Pharma AG, Wolhusen, Switserland) in the empty extraction socket (delayed implant placement, control group) or by filling the gap between the implant and buccal bone wall (immediate implant placement, test group).

Control group; Test group

Socket seal (Mucograft Seal, Geistlich Pharma AG, Wolhusen, Switserland) PROCEDURE

The occlusal aspect of the grafted socket in the delayed implant placement/control group is closed with a collagen matrix.

Control group

Eligibility Criteria

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

You may qualify if:

• at least 18 years old
• good oral hygiene defined as full-mouth plaque score ≤ 25% (O'Leary et al. 1972)
• presence of a single-rooted tooth in the anterior maxilla (15-25) that needs to be extracted for any reason with at least one neighboring tooth present
• at least 3 mm bone available at the apical or palatal aspect of the alveolus to ensure primary implant stability
• intact or nearly intact buccal bone wall at the time of extraction (max 3 mm bone missing = max 6 mm distance from free gingival margin to buccal bone crest)

You may not qualify if:

• systemic diseases
• smoking
• untreated periodontal disease
• untreated caries lesions

Sponsors & Collaborators

• University Ghent: lead

Study Sites (2)

Ghent University

Ghent, Oost-Vlaanderen, 9000, Belgium

RECRUITING

UCL St Luc

Liège, Belgium

RECRUITING

Related Publications (11)

• Avila-Ortiz G, Elangovan S, Kramer KW, Blanchette D, Dawson DV. Effect of alveolar ridge preservation after tooth extraction: a systematic review and meta-analysis. J Dent Res. 2014 Oct;93(10):950-8. doi: 10.1177/0022034514541127. Epub 2014 Jun 25.

  PMID: 24966231 BACKGROUND

• Bittner N, Schulze-Spate U, Silva C, Da Silva JD, Kim DM, Tarnow D, Gil MS, Ishikawa-Nagai S. Changes of the alveolar ridge dimension and gingival recession associated with implant position and tissue phenotype with immediate implant placement: A randomised controlled clinical trial. Int J Oral Implantol (Berl). 2019;12(4):469-480.

  PMID: 31781700 BACKGROUND

• Cosyn J, De Bruyn H, Cleymaet R. Soft tissue preservation and pink aesthetics around single immediate implant restorations: a 1-year prospective study. Clin Implant Dent Relat Res. 2013 Dec;15(6):847-57. doi: 10.1111/j.1708-8208.2012.00448.x. Epub 2012 Feb 29.

  PMID: 22376232 BACKGROUND

• Cosyn J, Eghbali A, Hermans A, Vervaeke S, De Bruyn H, Cleymaet R. A 5-year prospective study on single immediate implants in the aesthetic zone. J Clin Periodontol. 2016 Aug;43(8):702-9. doi: 10.1111/jcpe.12571. Epub 2016 Jun 13.

  PMID: 27120578 BACKGROUND

• Cosyn J, Pollaris L, Van der Linden F, De Bruyn H. Minimally Invasive Single Implant Treatment (M.I.S.I.T.) based on ridge preservation and contour augmentation in patients with a high aesthetic risk profile: one-year results. J Clin Periodontol. 2015 Apr;42(4):398-405. doi: 10.1111/jcpe.12384. Epub 2015 Mar 31.

  PMID: 25728590 BACKGROUND

• Kan JY, Rungcharassaeng K, Lozada JL, Zimmerman G. Facial gingival tissue stability following immediate placement and provisionalization of maxillary anterior single implants: a 2- to 8-year follow-up. Int J Oral Maxillofac Implants. 2011 Jan-Feb;26(1):179-87.

  PMID: 21365054 BACKGROUND

• Migliorati M, Amorfini L, Signori A, Biavati AS, Benedicenti S. Clinical and Aesthetic Outcome with Post-Extractive Implants with or without Soft Tissue Augmentation: A 2-Year Randomized Clinical Trial. Clin Implant Dent Relat Res. 2015 Oct;17(5):983-95. doi: 10.1111/cid.12194. Epub 2013 Dec 27.

  PMID: 24373419 BACKGROUND

• Sanz M, Lindhe J, Alcaraz J, Sanz-Sanchez I, Cecchinato D. The effect of placing a bone replacement graft in the gap at immediately placed implants: a randomized clinical trial. Clin Oral Implants Res. 2017 Aug;28(8):902-910. doi: 10.1111/clr.12896. Epub 2016 Jun 7.

  PMID: 27273298 BACKGROUND

• Seyssens L, Eghbali A, Cosyn J. A 10-year prospective study on single immediate implants. J Clin Periodontol. 2020 Oct;47(10):1248-1258. doi: 10.1111/jcpe.13352. Epub 2020 Sep 2.

  PMID: 32748983 BACKGROUND

• Yoshino S, Kan JY, Rungcharassaeng K, Roe P, Lozada JL. Effects of connective tissue grafting on the facial gingival level following single immediate implant placement and provisionalization in the esthetic zone: a 1-year randomized controlled prospective study. Int J Oral Maxillofac Implants. 2014 Mar-Apr;29(2):432-40. doi: 10.11607/jomi.3379.

  PMID: 24683571 BACKGROUND

• Zuiderveld EG, Meijer HJA, den Hartog L, Vissink A, Raghoebar GM. Effect of connective tissue grafting on peri-implant tissue in single immediate implant sites: A RCT. J Clin Periodontol. 2018 Feb;45(2):253-264. doi: 10.1111/jcpe.12820. Epub 2017 Dec 5.

  PMID: 28941303 BACKGROUND

Central Study Contacts

Jan Cosyn, Professor

CONTACT

+3293324000; jan.cosyn@ugent.be

Lorenz Seyssens, Phd candidate

CONTACT

lorenz.seyssens@ugent.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: As this RCT concerns a surgical intervention, patients and treating clinicians can not be masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicenter randomized controlled study with 2 treatment arms (control: delayed implant placement; test: immediate implant placement) and 6 centers

Study Record Dates

• First Submitted: October 17, 2020
• First Posted: February 5, 2021
• Study Start: January 1, 2021
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: February 2, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2)