Actively Recruiting

Phase Not Applicable
Age: 20Years +
All Genders
Healthy Volunteers
ID06820489

A Three-arm Randomized Controlled Trial Comparing Transmucosal Augmentation Techniques in Immediate Implant Placement

Led by University Ghent · Updated on 2026-01-09

54

Participants Needed

1

Research Sites

260 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research evaluates three different soft-tissue augmentation methods for patients receiving a single immediate implant placement in the front upper jaw (premaxilla). The study aims to find which method best prevents soft tissue loss around the implant one millimeter below the implant shoulder. It compares conventional connective tissue grafting with two newer techniques, scarf connective tissue graft and the dual zone concept, in a randomized controlled trial involving adults with good oral health. The study is led by University Ghent and involves 54 patients randomly assigned to one of the three treatment groups. All participants receive immediate implant placement combined with socket grafting. The three groups differ in their soft-tissue augmentation approach: the conventional method places a connective tissue graft inside a pouch on the buccal side; the scarf graft fixes a smaller tissue graft directly onto the buccal mucosa without a pouch; and the dual zone technique condenses bone material up to the soft tissue margin without using a connective tissue graft. After implant placement, a healing abutment is installed and replaced by a provisional crown two days later. Sutures are managed depending on the group and surgical needs. Participants are evaluated through cone-beam CT scans, clinical measurements, intra-oral scans, and photos at baseline and follow-ups at one and five years. The main outcome is successful regeneration measured by tissue maintenance at the specified level. Additional outcomes include bone loss, soft tissue thickness, patient pain reports, oral health indicators, and esthetic scores. Data analysis uses statistical tests to compare results across groups, with safety and esthetic results monitored over time.

CONDITIONS

Brief Title

Comparison of Three Transmucosal Augmentation Techniques in Immediate Implant Placement

Who Can Participate

Age: 20Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • At least 20 years old
  • Good oral hygiene defined as full-mouth plaque score C= 25%
  • Presence of an incisor, cuspid or premolar in the maxilla 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 as assessed on CBCT to ensure primary implant stability
  • Intact buccal bone wall (type I) or limited buccal bone dehiscence (type IIa or IIb) at the time of extraction
  • Written informed consent.
Not Eligible

You will not qualify if you...

  • Pregnancy
  • Systemic diseases
  • Smoking; suppuration
  • 1 mm gingival asymmetry between the failing and contralateral tooth

  • Untreated periodontal disease
  • Untreated caries lesions

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 1 week

Participants receive immediate implant placement with one of three soft-tissue augmentation techniques: conventional connective tissue graft in a buccal pouch, scarf connective tissue graft fixed onto the buccal mucosa, or bone material condensed up to the buccal soft tissue margin. A healing abutment is installed and replaced by a provisional implant crown 2 days later. Sutures are removed about 1 week after surgery when applicable.

1 surgery visit and follow-up visits within 1 week

Follow-up

Duration - 5 years

Participants have clinical and imaging assessments to evaluate tissue changes, esthetic outcomes, and patient-reported results at 1 and 5 years after treatment.

Multiple follow-up visits including assessments at 1 year and 5 years

Trial Site Locations

Total: 1 location

1

Ghent University Hospital

Ghent, East Flanders, Belgium, 9000

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Research Team

V

Véronique Christiaens, PhD

J

Jan Cosyn, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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Published Research Related To This Trial

Effect of connective tissue grafting on buccal bone changes based on cone beam computed tomography scans in the esthetic zone of single immediate implants: A 1-year randomized controlled trial.

Elise G Zuiderveld, Wouter G van Nimwegen, Henny J A Meijer...

https://pubmed.ncbi.nlm.nih.gov/32918332

Clinical evaluation of the buccal aspect around immediate implant using dual zone therapeutic concept versus buccal gap fill to bone level: A randomized controlled clinical trial.

Remon Wahid Wanis, Manal Mohamed Hosny, Hani ElNahass

https://pubmed.ncbi.nlm.nih.gov/35507735

Management of the extraction socket and timing of implant placement: Consensus report and clinical recommendations of group 3 of the XV European Workshop in Periodontology.

Maurizio S Tonetti, Ronald E Jung, Gustavo Avila-Ortiz...

https://pubmed.ncbi.nlm.nih.gov/31215112

Immediate single-tooth implant placement with simultaneous bone augmentation versus delayed implant placement after alveolar ridge preservation in bony defect sites in the esthetic region: A 5-year randomized controlled trial.

Kirsten W Slagter, Henny J A Meijer, Diederik F M Hentenaar...

https://pubmed.ncbi.nlm.nih.gov/33724473

Flapless immediate implant placement and provisionalization in periodontal patients: A retrospective consecutive case-series study of single-tooth sites with dehiscence-type osseous defects.

Alberto Sicilia-Felechosa, Adolfo Pereira-Fernández, Javier García-Lareu...

https://pubmed.ncbi.nlm.nih.gov/31755601

Linear and profilometric changes of the mucosa following soft tissue augmentation in the zone of aesthetic priority: A systematic review and meta-analysis.

Gerry M Raghoebar, Anke Korfage, Henny J A Meijer...

https://pubmed.ncbi.nlm.nih.gov/34642988