NCT04731545

Brief Summary

The utilization of SLActive implants which allow more rapid osseointgeration with 3 to 4 weeks. will be placed in thin buccal bone as immediate implants to determine the resorption compared to thick buccal bone

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

January 15, 2017

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

January 25, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 1, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

January 23, 2024

Status Verified

January 1, 2024

Enrollment Period

4.5 years

First QC Date

January 25, 2021

Last Update Submit

January 22, 2024

Conditions

Keywords

immediate implantesthetic zonebuccal plateSLActive

Outcome Measures

Primary Outcomes (1)

  • Bucccal bone changes

    standardized Cone beam computed Tomography The radiograph will be taken preoperatively and 12 month after. The pre and post operative cone beams will be compared to each other observing any changes of the buccal bone at 2 , 4 and 6 mm from the crest, the measurements will be in mm

    12 months post loading

Secondary Outcomes (7)

  • Implant stability

    3 months

  • Crestal bone changes

    12 months post loading

  • Soft tissue thickness

    3 months

  • Post operative pain and swelling

    1 week

  • Buccal bone thickness

    3 months

  • +2 more secondary outcomes

Study Arms (2)

thin buccal bone

ACTIVE COMPARATOR
Device: immediate implant placement

thick buccal bone

ACTIVE COMPARATOR
Device: immediate implant placement

Interventions

Minimally traumatic tooth extraction, immediate implant placement and hard tissue grafting. loading after 3 months.

thick buccal bonethin buccal bone

Eligibility Criteria

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

You may qualify if:

  • Single bounded irrestorable tooth in the esthetic zone that needs to be extracted.
  • Healthy systemic condition.
  • Type I socket with a minimum of 1mm of buccal bone thickness prior to extraction. (Morton et al., 2014)
  • Sufficient bone apical to the socket for implant primary stability. (Morton et al., 2014)
  • Good oral hygiene.
  • Patient accepts a minimum of three-year follow-up period (cooperative patients).

You may not qualify if:

  • Signs of acute infection related to the area of interest.
  • Patients with parafunctional habits (Lobbezoo et al. 2006 and Roelhing et al. 2016).
  • Smokers (Lambert et al. 2000).
  • Pregnant females.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Oral and Dental Medicine Cairo University

Cairo, Egypt

Location

Related Publications (1)

  • ElNahass H, Tawfik OK, Naiem SN, Zazou N, Moussa M. Evaluation of buccal bone resorption in immediate implant placement in thin versus thick buccal bone plates: An 18-month follow-up prospective cohort study. Clin Implant Dent Relat Res. 2024 Jun;26(3):532-544. doi: 10.1111/cid.13312. Epub 2024 Feb 21.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assitant Professor

Study Record Dates

First Submitted

January 25, 2021

First Posted

February 1, 2021

Study Start

January 15, 2017

Primary Completion

July 1, 2021

Study Completion

June 1, 2022

Last Updated

January 23, 2024

Record last verified: 2024-01

Locations