Effect of Sodium Alendronate on the Final Implant Stability.

NCT ID: NCT05162885

Last Updated: 2021-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-01

Study Completion Date

2022-10-01

Brief Summary

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evaluation of the final implant stability after its placement in sockets preserved with two different socket preservation materials

Detailed Description

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compare the stability of implant placement using Osstell ISQ "resonance frequency analyzer", and marginal bone resorption and bone density around implant by X-ray analysis in different socket preservation techniques comparing sodium alendronate with the sticky bone graft technique

Conditions

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Anterior Labial Wall Defect

Keywords

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Stability, Sodium Alendronate, Implant, Sticky bone

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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implant placement in defective Sockets preserved with alendronic acid sponge

anesthesia according the site of implant placement were administered using mepivacaine HCl (2%) with levonordefrin 1:20 000 (Scandonest 2%; Septodont, Saint- Maur-des-Fossés, France). Injection to control pain and bleeding for hemostasis. Crestal incision with a full thickness mucoperiosteal flap was reflected .A pilot drill will be used to start the osteotomy preparation, then different drilling sizes will be used to attain the final drill size and the planed implant height and width according to Cone Beam CT. Implants were screwed directly into the osteotomy site, primarily the screwing was done mechanically by Fixture Mount Connection attached to the implant carrier.

The created gap sutured passively to allow tension-free interrupted closure using 3-0 coated undyed braided polyglactin 910 suture material.

Group Type ACTIVE_COMPARATOR

Socket Preservation technique

Intervention Type PROCEDURE

Implant placement after Socket preservation Technique with sodium alderonate versus sticky bone in salama\&salama Class 3 labial wall defect

Implant placement in Defective sockets preserved with sticky bone

anesthesia according the site of implant placement were administered using mepivacaine HCl (2%) with levonordefrin 1:20 000 (Scandonest 2%; Septodont, Saint- Maur-des-Fossés, France). Injection to control pain and bleeding for hemostasis. Crestal incision with a full thickness mucoperiosteal flap was reflected .A pilot drill will be used to start the osteotomy preparation, then different drilling sizes will be used to attain the final drill size and the planed implant height and width according to Cone Beam CT. Implants were screwed directly into the osteotomy site, primarily the screwing was done mechanically by Fixture Mount Connection attached to the implant carrier.

The created gap sutured passively to allow tension-free interrupted closure using 3-0 coated undyed braided polyglactin 910 suture material.

Group Type ACTIVE_COMPARATOR

Socket Preservation technique

Intervention Type PROCEDURE

Implant placement after Socket preservation Technique with sodium alderonate versus sticky bone in salama\&salama Class 3 labial wall defect

Interventions

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Socket Preservation technique

Implant placement after Socket preservation Technique with sodium alderonate versus sticky bone in salama\&salama Class 3 labial wall defect

Intervention Type PROCEDURE

Other Intervention Names

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Implant in socket preserved with sodium alenderonate drug

Eligibility Criteria

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Inclusion Criteria

* Patients with seeking implant drive prosthesis after socket has been preserved by either technique.
* Patients with seeking implant drive prosthesis with Salama Class 3 defective sockets.
* Both genders males and females will be included.

Exclusion Criteria

* General contraindications to implant surgery.
* Patient seeking immediate implant placement.
* Subjected to irradiation in the head and neck area less than 1 year before implantation.
* Untreated periodontitis.
* Poor oral hygiene and motivation.
* Uncontrolled diabetes.
* Pregnant or nursing.
* Substance abuse.
* Psychiatric problems or unrealistic expectations.
* Severe bruxism or clenching.
* Immunosuppressed or immunocompromised.
* Treated or under treatment with intravenous amino-bisphosphonates.
* Active infection or severe inflammation in the area intended for implant placement.
* Unable to open mouth sufficiently to accommodate the surgical tooling.
* Patients participating in other studies, if the present protocol could not be properly
* followed. Referred only for implant placement or unable to attend a 5-year follow-up
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Hossam Abdallah Mohammed Ghazzaly

H.Ghazzaly

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hossam Abdallah Mohammed Ghazally

Cairo, Manial, Egypt

Site Status RECRUITING

Countries

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Egypt

Facility Contacts

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Nadia Galal Galal, PHD

Role: primary

Other Identifiers

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omfs335

Identifier Type: -

Identifier Source: org_study_id