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Completed

NCT Number: NCT04824235

Alveolar Ridge Preservation Using Amniotic Chorion Membrane

the present study is to compare the amniotic chorion membrane (ACM) alone versus the amniotic chorion membrane combined with xenograft for their efficacy in alveolar ridge preservation procedures regarding volumetric changes assessed by cone beam computed tomography (CBCT).

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Key information

Conditions

Alveolar Ridge Preservation

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams Faculty of Dentistry

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients require extraction of a non-restorable (premolar or anterior tooth) located in the maxillary arch and needs implant restoration.
  • Type two sockets will be selected as revealed by Cone beam computed tomography(CBCT)
  • Absence of any systemic disease or drugs that contraindicate oral surgery using Modified Cornell Medical Index
  • Male and female within age range of 20-45 years.

Exclusion criteria

  • Smokers.
  • Patients with poor oral hygiene or non-compliant patients who are not willing to perform oral hygiene measures.
  • Pregnant and breast-feeding females.
  • Patients with acute peri-apical infection or sinus tract.
  • Vulnerable group of patients as handicapped patients, orphans,prisoners,etc

Treatment and study plan

Amniotic Chorion Membrane and Bio-Oss xenograft

Other

Bioxclude Amniotic Chorion Membrane with xenograft (Bio-Oss) for ridge preservation

Amniotic Chorion Membrane only

Other

Bioxclude Amniotic Chorion Membrane only

Primary outcomes

  1. Change in Bucco-lingual bone width

    Time frame: at baseline, 1 months and 4 months

    Bone width will be measured using bone caliper and radiographically

  2. Change in Corono-apical bone height

    Time frame: at baseline, 1 months and 4 months

    Bone height using a pre-fabricated stent.

  3. total bone volume change

    Time frame: at baseline, and 4 months

    It will be evaluated by the use of 3D scans of patient dental models

Sponsors and collaborators

Lead sponsor

Hams Hamed Abdelrahman

Other

Registry information

Official study title

Alveolar Ridge Preservation Using Amniotic Chorion Membrane Alone or Combined With Xenograft (A Randomized Controlled Clinical Trial With Histological Evaluation)

Important dates

Study start
2020
Primary completion
2022
Study completion
2024
First posted
Apr 1, 2021
Registry last updated
Jan 7, 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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