Custom Provisionalisation

NCT07731854 | Completed

• 1 other identifier: S65361
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

Brief Summary

Fully digital immediate implant treatment by means of fully guided implant placement and custom designed provisionalisation with a individual designed abutment and temporary PMMA crown leads to better esthetic outcomes than free handed with regular provisionalisation on a temporary cylinder.

Conditions

Tooth Loss and Rehabillitation

Keywords

guided implant surgery; immediate implant treatment; esthetic outcome; provisionalisation

Outcome Measures

Primary Outcomes (3)

• mid-facial recession (mm)

  measurement CEJ to free gingival margin with periodontal probe

  6 months and 1 year after surgery

• PES (pink esthetic score)

  assesses the soft tissue (gums); score 0-20

  6 months and 1 year after surgery

• WES (white esthetic score

  Assesses the tooth itself in relation to the neigboring natural elements; score 0-20

  6 months and 1 year after surgery

Secondary Outcomes (3)

• buccal bone thickness

  at implant surgery, 6 months and 1 year after surgery

• Surgical time

  during surgery

• Implant success

  6 months and 1 year after surgery

Study Arms (2)

Digital workflow (Azento)

ACTIVE COMPARATOR

Fully guided implant placement + individualized abutment + digital prepared proviosional crown

Procedure: Fully guided implant placement; Procedure: individualised abutment + digital prepared provisional crown

Conventional workflow

PLACEBO COMPARATOR

Free handed Implant placement + provisional cylinder + conventional provisional crown

Procedure: Free handed implant placement; Procedure: Provisional Cylinder + conventional provisional crown

Interventions

Free handed implant placement PROCEDURE

immediate implant placement conventional workflow

Conventional workflow

Provisional Cylinder + conventional provisional crown PROCEDURE

immediate loading with conventional workflow

Conventional workflow

Fully guided implant placement PROCEDURE

immediate implant placement with digital workflow

Digital workflow (Azento)

individualised abutment + digital prepared provisional crown PROCEDURE

immediate loading with digital workflow

Digital workflow (Azento)

Eligibility Criteria

• Age: 25 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
• Males or females ASA I or II, between 25 to 80 years of age
• One tooth in the high esthetic region planned for extraction.
• Patient in good general health as documented by self-assessment.
• Patients must be committed to the study and must be willing to sign the informed consent.

You may not qualify if:

• Any disorder, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol
• Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial
• Participation in an interventional Trial with an investigational medicinal product (IMP) or device
• Any systemic medical condition that could interfere with the surgical procedure or planned treatment.
• Immunosuppression, Diabetes, Anticoagulation or Antiaggregatory medication.
• Current pregnancy or breast feeding/ lactating at the time of recruitment.
• Radiotherapy or Chemotherapy in head and neck area.
• Intravenous and oral bisphosphonate therapy.
• Smokers
• Unwillingness to return for the follow-up examination.
• Conditions or circumstances, in the opinion of the investigator, which could represent a general contra-indication for surgical procedure or would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, or unrealistic expectations.
• Presence of osseous pathologies, that may interfere with normal wound healing.
• Presence of oral lesions (such as ulceration, malignancy).
• Local inflammation, including untreated periodontitis.
• Patients with inadequate oral hygiene or unmotivated for adequate home care

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• University Hospital, Ghent: collaborator

Study Sites (2)

UZ Gent

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

UZLeuven, Campus St. Raphaël, Department Oral Health Sciences, Periodontology

Leuven, Vlaams Brabant, 3000, Belgium

Location

MeSH Terms

Conditions

Tooth Loss

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Diseases

Study Officials

• Andy Temmerman, Professor

  UZLeuven, department of Oral Health Sciences, Periodontology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2026
• First Posted: July 28, 2026
• Study Start: May 29, 2022
• Primary Completion: December 31, 2025
• Study Completion: July 15, 2026
• Last Updated: July 28, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2)