NCT06526351

Brief Summary

The goal of this study is to assess clinical, radiological and patient centred outcomes of immediate and conventional implant loading protocols, and to compare clinical outcomes of these two different loading protocols (immediate and conventional) in combination with early implant placement of single implants in the esthetic zone of maxilla.

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
10mo left

Started Mar 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress72%
Mar 2024Mar 2027

Study Start

First participant enrolled

March 29, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 16, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 29, 2024

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

July 29, 2024

Status Verified

July 1, 2024

Enrollment Period

2.9 years

First QC Date

July 16, 2024

Last Update Submit

July 27, 2024

Conditions

Dental Implant

Keywords

early implant placementimmediate provisionalization

Outcome Measures

Primary Outcomes (2)

  • Marginal bone level changes

    Marginal bone level will be monitored using periapical radiographs taken with paralleling technique, using custom silicone holder fabricated for each patient. X-rays will be taken on the day of the provisional restoration placement, final restoration placement, and one year after final restoration.

    1 year

  • Pink esthetic score

    Esthetic outcome for the peri-implant mucosa will be assessed from the photographs taken at the definitive restoration delivery and 1 year follow-up visit. Seven variables (mesial papilla, distal papilla, soft-tissue level, soft- tissue contour, alveolar process deficiency, soft-tissue color and texture) are assessed with a score 0, 1 or 2. Highest possible score is 14.

    1 year

Secondary Outcomes (5)

  • Implant survival

    1 year

  • Facial bone wall width

    1 year

  • Alveolar ridge volume

    1 year

  • Patient satisfaction

    1 year

  • Impact of oral health on patient's quality of life

    1 year

Study Arms (2)

Test group (Early implant placement + immediate provisionalization)

EXPERIMENTAL

Patients in test group receive an implant 6 to 8 weeks following tooth extraction with immediate provisional restoration

Device: Early implant placement with immediate provisional restoration

Control group (Early implant placement + delayed loading)

ACTIVE COMPARATOR

Patients in control group receive an implant 6 to 8 weeks following tooth extraction with submerged healing and conventional loading

Device: Early implant placement with delayed loading

Interventions

Early implant placement with immediate provisional restorationDEVICE

Implants placed following early implant placement protocol with soft tissue healing (6-8 weeks after tooth extraction). GBR procedure performed together with implant placement. Immediate provisional restoration will be delivered.

Test group (Early implant placement + immediate provisionalization)
Early implant placement with delayed loadingDEVICE

Implants placed following early implant placement protocol with soft tissue healing (6-8 weeks after tooth extraction). GBR procedure performed together with implant placement. Delayed loading protocol followed.

Control group (Early implant placement + delayed loading)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Single failing tooth in the esthetic zone of maxilla (second premolar to second premolar)
  • Patients older than 18 years
  • Healthy patients ASA I and II
  • Non-smokers/Light smokers (\<10 cigarettes per day)
  • Adequate bone volume apical and palatal to the failing tooth to allow for sufficient primary - implant stability of regular diameter implant

You may not qualify if:

  • Implants adjacent to the failing teeth
  • Active periodontal infection
  • Severe bruxism
  • Systemic or local conditions that contraindicates dental implant surgery - Heavy smokers (\>10 cigarettes per day)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Implant Center, School of Dental Medicine, Univeristy of Blegrade

Belgrade, 11000, Serbia

RECRUITING

Study Officials

  • Aleksa Markovic, Professor

    Chair of Implant Center, School of Dental Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Aleksa Markovic, Professor

CONTACT

+381116964380maleksa64@gmail.com

Marko Magic, PhD

CONTACT

markomagic@ymail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The study is designed as a single center, double-blinded, randomized, patient-oriented, controlled clinical trial.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 16, 2024

First Posted

July 29, 2024

Study Start

March 29, 2024

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

July 29, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)