NCT05261334

Brief Summary

comparing socket shield technique with early implant placement with contour augmentation in preserving the bone contour

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

January 28, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 2, 2022

Completed
29 days until next milestone

Study Start

First participant enrolled

March 31, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

March 25, 2022

Status Verified

March 1, 2022

Enrollment Period

1 year

First QC Date

January 28, 2022

Last Update Submit

March 11, 2022

Conditions

Bone LossBone Resorption

Outcome Measures

Primary Outcomes (1)

  • facial bone thickness

    using superimposed CBCT images

    12 months

Secondary Outcomes (2)

  • facial bone height changes

    12 months

  • Soft tissue height changes

    12 months

Study Arms (2)

socket shield technique

ACTIVE COMPARATOR

immediate implant placement with socket shield technique

Procedure: contour augmentation

contour augmentation

ACTIVE COMPARATOR

early implant placement with contour bone augmentation

Procedure: contour augmentation

Interventions

contour augmentationPROCEDURE

early implant placement with contour bone augmentation

contour augmentationsocket shield technique

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Non-restorable maxillary teeth in the esthetic zone
  • Intact adjacent teeth
  • Adequate palatal and apical bone that allows achieving implant primary stability.
  • Type I socket
  • ≥18 years
  • ≤ 60 years
  • Systemically healthy patients

You may not qualify if:

  • Extraction sockets with acute or chronic infection or with adjacent infected teeth
  • Heavy Smokers \> than 10 cigarettes daily
  • Cancer patients undergoing radiotherapy or chemotherapy during or within the last 6 months.
  • Unmotivated patients to maintain adequate oral hygiene to follow up.
  • Patients with physical disabilities that could affect follow up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, 11553, Egypt

Location

MeSH Terms

Conditions

Bone Diseases, MetabolicBone Resorption

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Prosthodontics, Faculty of Dentistry, Cairo University

Study Record Dates

First Submitted

January 28, 2022

First Posted

March 2, 2022

Study Start

March 31, 2022

Primary Completion

March 31, 2023

Study Completion

September 1, 2023

Last Updated

March 25, 2022

Record last verified: 2022-03

Locations

EG(1)