NCT07080710

Brief Summary

The goal of this clinical study is to learn how well immediate implant placement works in the front upper jaw (premaxilla) when using flapless guided surgery, hard and soft tissue augmentation, and immediate provisional crowns. It will also learn about the safety and esthetic results of this treatment approach. The main questions it aims to answer are: Primary: How much buccal bone thickness remains one year after implant placement 1mm below the implant shoulder? Secondary:

  • How do patients rate pain, healing, and esthetics after treatment?
  • Are there any complications over the course of five years?
  • How much buccal bone thickness remains one year after implant placement 3mm and 5mm below the implant shoulder?
  • Marginal bone loss at one-year and five-year follow-up?
  • Peri-implant health at one-year and five-year follow-up?
  • Soft tissue changes at one-year and five-year follow-up? Researchers will compare treatment results in patients with intact bone sockets to those with damaged (non-intact) sockets. Participants will:
  • Receive a dental implant and temporary crown on the same day as the tooth extraction
  • Undergo guided, flapless surgery with bone and soft tissue grafting
  • Take antibiotics and anti-inflammatories for 4 days after surgery
  • Visit the clinic at 1 week, 3 months, 1 year, and 5 years for follow-up exams
  • Have X-rays, digital scans, and photos taken to measure bone and soft tissue changes
  • Answer questions about pain and esthetic satisfaction

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
70mo left

Started Jul 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress13%
Jul 2025Feb 2032

First Submitted

Initial submission to the registry

June 23, 2025

Completed
8 days until next milestone

Study Start

First participant enrolled

July 1, 2025

Completed
22 days until next milestone

First Posted

Study publicly available on registry

July 23, 2025

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2032

Last Updated

November 18, 2025

Status Verified

November 1, 2025

Enrollment Period

1.6 years

First QC Date

June 23, 2025

Last Update Submit

November 14, 2025

Conditions

Bone Resorption

Keywords

dental implant, single-toothImmediateconnective tissue graftsocket graftingintact alveolusnon-intact alveolus

Outcome Measures

Primary Outcomes (1)

  • Buccal bone thickness -1 (mm)

    Buccal bone thickness at 1 mm below the implant shoulder at one-year follow-up as assessed on a three-dimensional radiograph.

    moment of enrollment and 1-year

Secondary Outcomes (6)

  • Patient reported outcomes

    one week after surgery

  • Pink Esthetic Score

    enrollment, 1-year, 5-year

  • Buccal bone thickness -3 and -5 (mm)

    enrollment and 1-year

  • Marginal bone loss

    1-, 5-year

  • Peri-implant health

    1-, 5-year

  • +1 more secondary outcomes

Study Arms (1)

Immediate implant placement

EXPERIMENTAL

State of the art immediate implant placement with socket grafting and soft tissue augmentation.

Procedure: Immediate implant placement

Interventions

Immediate implant placementPROCEDURE

Immediate implant placement with socket grafting and soft tissue augmentation. In cases with a buccal dehiscence \>3mm only this technique is applied. In cases with a buccal dehiscence between 4-6mm a collagen membrane is applied prior to socket grafting. In cases with a buccal dehiscence \> 6 mm, a collagen membrane is also applied and a mixture of C-DBBM and autogenous bone chips (1:1 ratio) is used as grafting material.

Immediate implant placement

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • At least 20 years old
  • Good oral hygiene defined as full-mouth plaque score ≤ 25%
  • Presence of one or more incisors, cuspids or premolars in the maxilla that need 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 alveoli as assessed on a three-dimensional radiograph to ensure primary implant stability
  • Written informed consent.

You may not qualify if:

  • Pregnancy (will be explicitly asked)
  • Systemic diseases
  • Smoking; suppuration
  • \> 1 mm gingival asymmetry between the failing teeth and contralateral teeth
  • Failing teeth outside the bone envelop as assessed on a three-dimensional radiograph
  • Untreated periodontal disease; untreated caries lesions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ghent University

Ghent, East Flanders, 9000, Belgium

RECRUITING

Bv Dr. Cosyn

Zottegem, East Flanders, 9620, Belgium

RECRUITING

Related Publications (6)

  • Pitman J, Christiaens V, Callens J, Glibert M, Seyssens L, Blanco J, Cosyn J. Immediate implant placement with flap or flapless surgery: A systematic review and meta-analysis. J Clin Periodontol. 2023 Jun;50(6):755-764. doi: 10.1111/jcpe.13795. Epub 2023 Mar 5.

    PMID: 36843361BACKGROUND

  • Ickroth A, Christiaens V, Pitman J, Cosyn J. A Systematic Review on Immediate Implant Placement in Intact Versus Non-Intact Alveolar Sockets. J Clin Med. 2025 Apr 3;14(7):2462. doi: 10.3390/jcm14072462.

    PMID: 40217911BACKGROUND

  • Furhauser R, Florescu D, Benesch T, Haas R, Mailath G, Watzek G. Evaluation of soft tissue around single-tooth implant crowns: the pink esthetic score. Clin Oral Implants Res. 2005 Dec;16(6):639-44. doi: 10.1111/j.1600-0501.2005.01193.x.

    PMID: 16307569BACKGROUND

  • Botticelli D, Berglundh T, Lindhe J. Hard-tissue alterations following immediate implant placement in extraction sites. J Clin Periodontol. 2004 Oct;31(10):820-8. doi: 10.1111/j.1600-051X.2004.00565.x.

    PMID: 15367183BACKGROUND

  • Assaf JH, Assaf DD, Antoniazzi RP, Osorio LB, Franca FM. Correction of Buccal Dehiscence During Immediate Implant Placement Using the Flapless Technique: A Tomographic Evaluation. J Periodontol. 2017 Feb;88(2):173-180. doi: 10.1902/jop.2016.160276. Epub 2016 Sep 13.

    PMID: 27620655BACKGROUND

  • Barone A, Toti P, Marconcini S, Derchi G, Saverio M, Covani U. Esthetic Outcome of Implants Placed in Fresh Extraction Sockets by Clinicians with or without Experience: A Medium-Term Retrospective Evaluation. Int J Oral Maxillofac Implants. 2016 Nov/Dec;31(6):1397-1406. doi: 10.11607/jomi.4646.

    PMID: 27861667BACKGROUND

MeSH Terms

Conditions

Bone Resorption

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal Diseases

Central Study Contacts

Véronique Christiaens, Phd

CONTACT

09/332 40 17vchristi.christiaens@UGent.be

Jan Cosyn, PhD

CONTACT

09/332 40 18jan.cosyn@UGent.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
As this prospective study concerns a surgical intervention, patients and treating clinicians can not be masked.
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Prospective cohort study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2025

First Posted

July 23, 2025

Study Start

July 1, 2025

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2032

Last Updated

November 18, 2025

Record last verified: 2025-11

Locations

BE(2)