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CompletedNCT05708196Updated Feb 1, 2023

Evaluation of β-tricalcium Phosphate/Calcium Sulfate Versus Allografts

An interventional study of Alloplast bone grafting material (EthOss, Ethoss Regeneration Ltd, Silsden, UK). and Allograft bone grafting material. in Tooth Extraction, sponsored by Mansoura University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-01.

Sponsored by Mansoura University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 7 months after the study started (first participant enrolled Jun 2021, registered Jan 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

Thirty healthy patients will be selected from the outpatient clinic of the Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University, to be included in this study with non-restorable posterior teeth.Patients will be selected according to the following criteria: 1) having a non-restorable posterior tooth. 2) being healthy, with no systemic diseases that might contraindicate receiving a dental implant. 3) having good oral hygiene. 4) aged between 18 to 45 years old. 5) having sufficient alveolar bone volume and height at the future implant site.Patients were classified into three groups:

  • Group I: ten extraction sockets left for normal healing (blood clot).
  • Group II: ten extraction sockets filled with Alloplast bone grafting material (EthOss, Ethoss Regeneration Ltd, Silsden, UK).
  • Group III: ten extraction sockets filled with Allograft bone grafting material.Evaluation and Follow-up

All patients will be evaluated clinically and radiographically during a follow up period of 4 months, where the following criteria will be evaluated:

A- Clinical evaluation:

  • Patients will be evaluated at 1 week, 4 weeks and 8 weeks.
  • Clinical evaluations of soft tissue healing, and keratinized tissue replacement will be assessed on the basis of the healing index proposed by Landry et al12.
  • The scores will assess healing on the basis of redness, presence of granulation tissue, bleeding, suppuration, and epithelization.
  • The surgical region will be examined clinically, if there is pain, redness, tissue resorption and bone graft stability.

B- Radiographic evaluation:

  • Cone Beam Computed Tomography scan will be taken immediately after implant placement, and after 12 months.
  • All patient scans will be taken by a Planmeca ProMax 3D unit (Planmeca OY, Helsinki, Finland) using fixed imaging parameter at every scan. All DICOM data will then be analyzed using On Demand 3D software (Version 1, Cyber Med, Seoul, South Korea).
  • The vertical and horizontal measurements will be measured.
  • The apico-coronal dimension will be calculated, the bottom of the socket will be considered the most apical point, whereas the alveolar bone margin will be considered the most coronal point of the socket bone wall.

C- Histological evaluation:

  • Bone samples will be collected with trephine bur before implant placement, then fixed in 10% neutral buffered formalin for 24 hours, then transferred to 14% neutral buffered Ethylenediaminetetraacetic acid (EDTA) for decalcification 13. After confirming adequate decalcification, the specimens will be processed and embedded in paraffin blocks in the Pathology department, faculty of Medicine, Mansoura university for histological assessment, then stained with haematoxylin and eosin (H\&E) as a routine stain to evaluate the quality of newly formed bone.
02

Conditions studied

  • Tooth Extraction
03

In context

Lead sponsor

Mansoura University is the lead sponsor of 1,077 studies on the registry; 183 are open to participants now.

Of its 9 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
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • having a non-restorable posterior tooth.
  • being healthy, with no systemic diseases that might contraindicate receiving a dental implant.
  • having good oral hygiene.
  • aged between 18 to 45 years old.
  • having sufficient alveolar bone volume and height at the future implant site

Exclusion criteria

Exclusion Criteria:

  • having received radiation therapy at the head and neck area or chemotherapy in the past 12 months.
  • having uncontrolled diabetes.
  • having poor oral hygiene or motivation.
  • having bruxism or other parafunctional habit.
  • having infection or inflammation at the proposed implant site.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
30 participants (actual)

Study arms

  • No intervention
    control group

    ten extraction sockets left for normal healing (blood clot).

  • Experimental
    group 2

    ten extraction sockets filled with Alloplast bone grafting material (EthOss, Ethoss Regeneration Ltd, Silsden, UK).

    Other: Alloplast bone grafting material (EthOss, Ethoss Regeneration Ltd, Silsden, UK).

  • Experimental
    group 3

    ten extraction sockets filled with Allograft bone grafting material.

    Other: Allograft bone grafting material.

Interventions

  • OtherAlloplast bone grafting material (EthOss, Ethoss Regeneration Ltd, Silsden, UK).

    After tooth extraction, the tooth socket will begrafted with Alloplast grafting material

  • OtherAllograft bone grafting material.

    After tooth extraction, the tooth socket will be grafted with allograft grafting material

06

What researchers measure

Primary outcomes

  1. Bone density measurement

    CBCT will be used to assess bone density categories and HU

    Time frame: 4 months

07

Study locations

1 site
  • Heba Elsheikh
    Mansoura, 002, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 1, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05708196
Lead sponsor
Mansoura University
Responsible party
Heba Elsheikh (assistant professor of oral and maxillofacial surgery, Mansoura University) — Principal investigator
First posted
Feb 1, 2023
Start date
Jun 1, 2021
Primary completion
Oct 1, 2021
Completion
Oct 1, 2022
Last update
Feb 1, 2023

Oversight

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

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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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