Alveolar Ridge Preservation Using Collagen Material and Allograft

September 21, 2022 updated by: Yasmine Fouad

Alveolar Ridge Preservation Using Collagen Material and Allograft: A Randomized Controlled Trial

Seven Patients who need implants to replace non-restorable teeth in the esthetic zone.

Intervention Group (1): Seven extraction sockets that received the collagen matrix (Collagen cone) for alveolar ridge preservation.

Comparison Group (2): Seven extraction sockets that were treated with mineralized cortico-cancellous bone allograft for alveolar ridge preservation.

Outcome

  1. Alveolar ridge preservation both in height and in width to improve implant success rate

    • The height of alveolar ridge was assessed clinically using a periodontal probe.
    • The width of the alveolar ridge was measured after three months after extraction using a caliper clamp.

    • Changes in the width and height of alveolar bone were evaluated in merged axial and sagittal views using the I-CAT superimposition system (CBCT).

      2- Evaluation of newly formed bone quality was performed by histological examination and histomorphometric analysis.

      3- Immuno-histochemical staining was done using polyclonal antibody to detect (BMP-2) marker of bone formation

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The aim of the present study was to compare three months post-extraction augmented ridge using collagen matrix versus mineralized cortico-cancellous bone allograft. This comparison was done clinically, histologically, immunohisto-chemically and radiologically.

• Clinical parameters included; vertical bone height and bone width that were recorded at baseline and at three months after extraction. Moreover, histomorphometric parameters included; area fraction of osteoid and mature bone three months after extraction by histomorphometric analysis. Immunohistochemical analysis using polyclonal antibody to detect BMP-2 marker of bone formation. Radiographic parameters included superimposition of baseline CBCT, three months after extraction and another one six months after loading with subsequent measurement of bone height, bone width and bone density.

A core biopsy was taken three months after tooth extraction which has undergone histomorphometric and immunohistochemical analysis; implant placement was also done at the same time.

In the present study, it was found that the mean bone height decreased with a higher percent in collagen matrix group than mineralized cortico-cancellous bone allograft group with a non significant difference between both groups.

In addition, this study showed that the mean bone width decreased more in collagen matrix group than mineralized cortico-cancellous bone allograft group with a non significant difference between them.

Moreover, in the present study, Histomorphometric analysis revealed new bone trabeculae formation with osteoblastic rimming, the surrounding fibrous tissue is cellular and remnants of the graft materials was detected , with no marked difference in the amount of newly formed bone between two groups .

Regarding immunohistochemical analysis in both groups, the osteoblasts in the fibrous tissue and osteocytes in newly formed bone are showing nuclear staining, with increasing area of immunopositive cells in mineralized cortico-cancellous bone allograft group.

Radiographically, CBCT superimposition revealed that a greater percent decrease in bone height was denoted in collagen matrix than mineralized cortico-cancellous bone allograft group with a significant difference between both groups after 3 and 6 months.

Accordingly bone width showed a higher decrease in mineralized cortico-cancellous bone allograft group than Collagen matrix group with a non significant difference between both groups after 3 and 6 months.

Finally, bone density showed a greater decrease in Collagen matrix group than mineralized cortico-cancellous bone allograft group with a non significant difference after 3 months but significant difference was found after 6 months between both groups.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
14

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients were medically free .
  2. Two teeth indicated for extraction due to either severe decay, tooth fracture or failed endodontic treatment.

Exclusion Criteria:

  1. Patients with poor oral hygiene or not willing to perform oral hygiene measures.
  2. Pregnant and breast-feeding females.
  3. Smokers , Teeth with periodontal or periapical infections.
  4. Patients with malocclusion.
  5. All patients who had known contraindication to dental implant surgery (e.g: bleeding tendency, radiotherapy, taking bisphosphonate)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Collagen cone
Collagen matrix
Other: Collagen cone
Collagen matrix
Active Comparator: Allograft
mineralized corticocancellous allograft
Other: Allograft
Corticocancellous mineralized allograft

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
clinical score
Time Frame: change from baseline at 12 weeks
Dimensional changes in alveolar ridge after alveolar ridge preservation both clinically and radiographically
change from baseline at 12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
BMP-2
Time Frame: detected at 12 weeks
Bone morphogenic protein -2 immunopositive cells in immunostained sections
detected at 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yasmine Fouad

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Hala A Abuel-Ela, Professor, Faculty of Dentistry Ain Shams university

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 2, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 21, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 21, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 22, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 23, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FDASU-RECD 071402

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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