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OpenTrials
Completed

NCT Number: NCT05683509

Alveolar Ridge Preservation With Layered Collagen and Xenograft

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

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Key information

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry Ain Shams University

Cairo, Cairo Governorate, 4393005, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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).

Treatment and study plan

deep collagen layer, xenograft and collagen membrane

Procedure

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

xenograft and collagen membrane

Procedure

Alveolar ridge preservation is done using xenograft and collagen membrane only

Primary outcomes

  1. Measuring the clinical alveolar ridge changes

    Time frame: at baseline and 4 months

    Measuring the thickness of the alveolar ridge in mm

  2. Measuring the radiographic change in the buccal bone thickness

    Time frame: at baseline and 4 months

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

  3. Measuring the radiographic alveolar ridge dimensional changes

    Time frame: at baseline and 4 months

    Measuring the bone density in hounsfield units (HU)

Secondary outcomes

  1. Histological assessment of core biopsy

    Time frame: 4 months post operatively

    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

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Biologically Oriented Alveolar Ridge Preservation With Layered Collagen and Xenograft (A Randomized Controlled Clinical Trial With Histological Evaluation)

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Jan 13, 2023
Registry last updated
Feb 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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