Using Combination of Synthetic Bone Substitutes During Extractions

Phase 3 Study of Using Combination of Bi Phasic Calcium Phosphate and Bu Phasic Calcium Sulphate During Extractions

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01503593

Enrollment

Registered

2012-01-04

Start date

2012-05-31

Completion date

2013-05-31

Last updated

2012-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alveolar Bone Losses, Dental Caries, Periodontitis

Brief 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.

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

Interventions

DEVICECalcium Phosphate, Calcium Sulphate

1cc of Calcium Phosphate and 1cc of Calcium Sulphate

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

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

Design outcomes

Primary

Measure	Time frame	Description
The change of the dimension of the alveolar ridge	Immediatly after tooth extraction (up to 10 minutes after the extraction) and 4 monthes after extraction	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

Secondary

Measure	Time frame	Description
Post operative adverse effects	immediate after the extraction and until 4 monthes after	The investigators will record the optionally adverse effect such as edema, infection, pain, exposure of the membrane.

Contacts

Primary ContactDr. Yaniv Mayer, DMD

dr.yaniv.mayer@gmail.com+972546565905

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026