CClinicalTrials.gg
Status unknownNCT01503593Updated May 30, 2012

Using Combination of Synthetic Bone Substitutes During Extractions

A Phase 3 interventional study of Calcium Phosphate, Calcium Sulphate in Periodontitis, Dental Caries and Alveolar Bone Losses, sponsored by Rambam Health Care Campus. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-05-30.

Sponsored by Rambam Health Care Campus · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2012), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
40
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

The study was designed to assess the effectiveness of conservation ridge preservation (horizontal and vertical dimension) after tooth extraction with and without combination of bone substitutes based on synthetic (calcium sulfate mixed with phosphate.

Read the detailed description

Using the combination of these two bone substitute is taken in order to diminish the alveolar ridge alternations after tooth extraction. the investigator will measure the horizontal and vertical changes (primary outcome) and the adverse effects (secondary outcome)in 4 months period

02

Conditions studied

  • Periodontitis
  • Dental Caries
  • Alveolar Bone Losses
03

In context

Alveolar Bone Loss

297 studies on the registry are indexed under Alveolar Bone Loss; 76 are open to participants now.

This study's planned enrollment of 40 is above the median of 25 across 254 interventional studies indexed under Alveolar Bone Loss.

Browse Alveolar Bone Loss studies →

Lead sponsor

Rambam Health Care Campus is the lead sponsor of 456 studies on the registry; 33 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Patients over age 18.
  2. Patients who require extraction of teeth for Periodontal or other dental reasons (up one tooth in each quarter when there are existing adjacent teeth).

Exclusion criteria

Exclusion Criteria:

  1. Inability to pass informed consent procedure
  2. Pregnant women
  3. Breastfeeding women
  4. Patient taking medications that affect bone metabolism such as bisphosphonates
  5. Extractions sites contaminated
  6. Smoking over 10 cigarettes a day
  7. Patients with removable prostheses
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
40 participants (estimated)

Study arms

  • No intervention
    Alveolar ridge dimensions

    Control group - Only extraction teeth

  • Experimental
    Alverolar ridge dimension

    Extraction of teeth and implant a bone substitute

    Device: Calcium Phosphate, Calcium Sulphate

Interventions

  • DeviceCalcium Phosphate, Calcium Sulphate

    1cc of Calcium Phosphate and 1cc of Calcium Sulphate

06

What researchers measure

Primary outcomes

  1. The change of the dimension of the alveolar ridge

    Measurement of socket width (aspect B/L) at three points Height: 1. Record-high ridge (buccal/lingual-palatal ) 2. 3 mm apically to the peak ridge (buccal/lingual-palatal ) 3. 6mm apically to the peak ridge (buccal/lingual-palatal ) Measurement of alveolar ridge height: Measured distance between the summit crater and the peak of the ridge and the center line connecting the CEJ of adjacent teeth

    Time frame: Immediatly after tooth extraction (up to 10 minutes after the extraction) and 4 monthes after extraction

Secondary outcomes

  1. Post operative adverse effects

    The investigators will record the optionally adverse effect such as edema, infection, pain, exposure of the membrane.

    Time frame: immediate after the extraction and until 4 monthes after

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 30, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01503593
Lead sponsor
Rambam Health Care Campus
Responsible party
Sponsor
First posted
Jan 4, 2012
Start date
May 2012
Primary completion
May 2013 (estimated)
Completion
May 2013 (estimated)
Last update
May 30, 2012

Study contacts

Dr. Yaniv Mayer, DMD
Contact
dr.yaniv.mayer@gmail.com
+972546565905
Yaniv Mayer, D.M.D.
principal investigator · Rambam Health Care Campus, Haifa, Israel

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2012. You cannot join it, but the record below documents what was studied.

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