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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03584984
Other study ID # 2807
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date August 1, 2018
Est. completion date July 1, 2019

Study information

Verified date July 2018
Source Cairo University
Contact Dina M. Al-Esawy, Masters
Phone 01206036365
Email dr.dina.alesawy@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Alveolar bone atrophy post-extraction has been well documented in the past years. normal healing event results in a minimal loss of vertical height (around 1 mm), but a substantial loss of width in the buccal-lingual plane (4-6 mm). Alveolar socket preservation is thought to deal with this issue as to prevent the loss of alveolar bone dimensions post extraction in the case of delayed implant placement


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date July 1, 2019
Est. primary completion date January 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria:

- Adult patients with hopeless mandibular molars indicated for extraction and implant placement in two stages that indicate socket preservation.

- Both sexes.

- No intraoral soft and hard tissue pathology.

- No systemic condition that contraindicate implant placement.

Exclusion Criteria:

- Presence of fenestrations or dehiscence of the residual bony Walls after extraction.

- Heavy smokers more than 20 cigarettes per day .(24)

- Patients with systemic disease that may affect normal healing.

- Psychiatric problems

- Disorders to implant are related to a history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site.

- Patients that refuse to be called back for implant placement post extraction.

- Patients that have exceeded bone resorption surrounding the tooth prior to extraction and require guided bone regeneration.

- Pregnant Females.

Study Design


Intervention

Procedure:
Mixture of Autogenous bone & Anorganic Bovine Bone (ABB)
Filling the socket with Mixing of autogenous bone graft and anorganic bovine bone in a 50:50 ratio
Anorganic Bovine Bone (ABB)
Filling the socket with Anorganic bovine bone graft material only
Absorbable gelatin sponge
Filling the socket with an absorbable gelatin sponge foam pack

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Outcome

Type Measure Description Time frame Safety issue
Primary Histomorphometrical bone analysis histological bone core analysis 6 month post primary surgery
Secondary Alveolar Bone marginal loss CBCT measurements of marginal bone dimensional difference 6 month post primary surgery
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