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CompletedNCT05683509Updated Feb 24, 2025

Alveolar Ridge Preservation With Layered Collagen and Xenograft

An interventional study of deep collagen layer, xenograft and collagen membrane and xenograft and collagen membrane in Alveolar Ridge Preservation, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-24.

Sponsored by Ain Shams University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled May 2022, registered Dec 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
20 Years to 45 Years
Sex
All
01

Study summary

alveolar ridge preservation using deep collagen layer, xenograft and collagen membrane seal versus the use of xenograft and collagen membrane seal alone. Measuring the clinical and radiographic alveolar ridge dimensional changes following after preservation at the time of implant placement

Read the detailed description

alveolar ridge preservation using deep collagen layer, xenograft and collagen membrane seal versus the use of xenograft and collagen membrane seal alone.

The primary objective of the study is measuring the clinical and radiographic alveolar ridge dimensional changes following the procedure 4 months post operatively

The secondary objective :

  • Histological assessment of alveolar bone specimens to assess bone remodeling and new bone formation in both studied groups after four months.
  • Patient satisfaction after implant placement
02

Conditions studied

  • Alveolar Ridge Preservation
03

In context

Lead sponsor

Ain Shams University is the lead sponsor of 1,932 studies on the registry; 433 are open to participants now.

Of its 33 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Systemically healthy patients (American Society of Anesthesiologists I; ASA I).

    • Patients diagnosed with single unrestorable molar teeth (socket type I) requiring extraction and implant placement (Elian et al.2007).
  • Teeth free from any infection or periapical pathosis.
  • Enough zone of keratinized tissue with at least 2mm.
  • Good compliance with the plaque control instructions following initial therapy.
  • Availability for follow up and maintenance program.

Exclusion criteria

Exclusion Criteria:

  • Bad oral hygiene.
  • Presence of smoking habit.
  • Presence of occlusal interferences
  • Pregnant females
  • Vulnerable group of patients (handicapped, mentally retarded and prisoners) (according to the recommendation of esthetical committee of Faculty of Dentistry Ain Shams University).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
20 participants (actual)

Study arms

  • Active comparator
    deep collagen layer, xenograft and collagen membrane

    Alveolar ridge preservation is done using deep collagen layer, xenograft and collagen membrane

    Procedure: deep collagen layer, xenograft and collagen membrane

  • Active comparator
    xenograft and collagen membrane

    Alveolar ridge preservation is done using xenograft and collagen membrane alone

    Procedure: xenograft and collagen membrane

Interventions

  • Proceduredeep collagen layer, xenograft and collagen membrane

    Alveolar ridge preservation is done using deep collagen layer, xenograft and collagen membrane

  • Procedurexenograft and collagen membrane

    Alveolar ridge preservation is done using xenograft and collagen membrane only

06

What researchers measure

Primary outcomes

  1. Measuring the clinical alveolar ridge changes

    Measuring the thickness of the alveolar ridge in mm

    Time frame: at baseline and 4 months

  2. Measuring the radiographic change in the buccal bone thickness

    Measuring the change in the thickness of the buccal ridge radiographically in mm

    Time frame: at baseline and 4 months

  3. Measuring the radiographic alveolar ridge dimensional changes

    Measuring the bone density in hounsfield units (HU)

    Time frame: at baseline and 4 months

Secondary outcomes

  1. Histological assessment of core biopsy

    The microscopic examination of the bone remodeling and new bone through tissue biopsy (fixation and staining of the tissues) to examine the newly formed cells and count them to determine the amount of newly tissue formed

    Time frame: 4 months post operatively

07

Study locations

1 site
  • Faculty of Dentistry Ain Shams University
    Cairo, Cairo Governorate 4393005, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from May 2022 to primary completion in Apr 2023, 11 months.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 12, 2022
First posted
Jan 13, 2023
StartActual
May 30, 2022
Primary completionActual
Apr 30, 2023
CompletionActual
Sep 1, 2024
Last update
Feb 24, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05683509
Responsible party
Sponsor
First posted
Jan 13, 2023
Start date
May 30, 2022
Primary completion
Apr 30, 2023
Completion
Sep 1, 2024
Last update
Feb 24, 2025

Study contacts

Hala Abu el ela, Prof
study chair · Faculty of dentistry ain shams university

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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