Effect of Recombinant Human Bone Morphogenetic Protein-2 With an Absorbable Collagen Sponge on Stability of Dental Implant: (Split Mouth Randomized Clinical Trial Study.

Study Overview
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Brief Summary
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Effect of Recombinant Human Bone Morphogenetic Protein-2 with an Absorbable Collagen Sponge on Stability of Dental Implant: (Split Mouth Randomized Clinical Trial Study.

Detailed Description
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The Primary outcome will be measuring the effect of rhBMP- 2/ACS in improving the secondary stability of dental implant by using RFA in comparison to control group. Secondary outcome association of the effect of other factors (ridge dimension, bone density) on dental implant stability.

Official Title
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Effect of Recombinant Human Bone Morphogenetic Protein-2 With an Absorbable Collagen Sponge on Stability of Dental Implant: (Split Mouth Randomized Clinical Trial Study of 6\12\2021 to20\4\2023

Conditions
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Hypertension, Diabetes Mellitus, Blood Disease

Intervention / Treatment
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* Biological: rhBMP-2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients have good oral hygiene. Systemic healthy individuals ,Age more than18 years. Healed edentulous area for at least 6 months after tooth extraction (delayed implant protocol). Patients have at least two missing teeth in the jaw (canine to 1st molar area) indicated for the dental implant. Exclusion Criteria: Presence of systemic diseases preventing implantation. Previous implantation or augmentation of the same region. The need for additional bone augmentation procedures (such as maxillary sinus augmentation) Partial or total edentulous ridge associated with a severe knife-edge ridge . Acute infection or any pathological lesion a the implant site. Allergy to one of the materials to be used during operation. Pregnancy. Radiation therapy, bisphosphonate drugs , Osteoradionecrosis.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Interventional Model Description: two groups; first group with protein , second group without (control)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: control group<br>group consist of 16 patients with no protein application | Biological: rhBMP-2<br>* Recombinant Human Bone Morphogenetic Protein-2 with an Absorbable Collagen Sponge .<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of Recombinant Human Bone Morphogenetic The Primary outcome will be measuring the effect of rhBMP- 2/ACS in improving the secondary stability of dental implant by using RFA in comparison to control group. | The topical application of rhBMP-2 in the osteotomy site has an effect through improve secondary stability of the dental implant. | At the time of surgery ,all measurment (primary stability) was taken which represented the base line data. |