NCT04224935

Brief Summary

evaluation of the use of collagen membrane inside the socket and outside it during immediate implant placement

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2018

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

December 1, 2018

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 1, 2020

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 13, 2020

Completed
Last Updated

February 18, 2026

Status Verified

February 1, 2026

Enrollment Period

1.1 years

First QC Date

January 1, 2020

Last Update Submit

February 16, 2026

Conditions

Keywords

immediate implant placementbadly decayed tooth in esthetic zonecollagen membranexenografttemporization

Outcome Measures

Primary Outcomes (1)

  • buccal plate of bone thickness

    assessment of the buccal plate of bone will be determined in mm from CBCT

    baseline 12 months

Secondary Outcomes (1)

  • soft tissue thickness (Volumetric assessment)

    baseline, 6 and 12 months

Study Arms (2)

collagen membrane inside

ACTIVE COMPARATOR

during immediate implant placement collagen membrane will be placed into the jumping gap

Procedure: Collagen membrane inside

collagen membrane outside

ACTIVE COMPARATOR

during immedoate implant placement collagen membrane will be placed on the outersurface of the buccal plate of bone

Procedure: Collagen membrane outside

Interventions

during immediate implant placement the collagen membrane will be placed in the jumping gap

collagen membrane inside

during immediate implant placement the collagen membarne will be placed on the surface of the buccal plate of bone

collagen membrane outside

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Systemically free patients (American Society of Anesthesiologists I; ASA I).
  • Age range (20 -50) years.
  • Good compliance with the plaque control instructions following initial therapy.
  • Patients diagnosed badly decayed tooth in esthetic zone indicated for immediate implant placement
  • Availability for follow up and maintenance program.

You may not qualify if:

  • Patient suffering from periodontitis
  • Presence of smoking habit.
  • Presence of occlusion interference.
  • Pregnant and lactating females.
  • Vulnerable group of patients (handicapped, mentally retarded and prisoners).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry Ain Shams University

Cairo, Cairo Governorate, Egypt

Location

Study Officials

  • Mai Shafik, professor

    Misr international univeristy

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

January 1, 2020

First Posted

January 13, 2020

Study Start

December 1, 2018

Primary Completion

January 1, 2020

Study Completion

January 1, 2020

Last Updated

February 18, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations