Effect of Sodium Alendronate on the Final Implant Stability.

Effect of Sodium Alendronate Versus Sticky Bone as Socket Preservation Materials on the Final Implant Stability. A Randomized Clinical Trial

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

Study Overview

• Status: Recruiting
• Conditions: Anterior Labial Wall Defect
• Intervention / Treatment: Procedure: Socket Preservation technique

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Manial
    • Cairo, Manial, Egypt, 11553
      • Recruiting
      • Hossam Abdallah Mohammed Ghazally
      • Contact: Nadia Galal Galal, PHD; Phone Number: 0020 01002177637; Email: Nadia.Galal@dentistry.cu.edu.eg
      • Principal Investigator: Nadia Galal Galal, PHD
      • Sub-Investigator: Mohammad Mohammed Omara, PHD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Procedure: Socket Preservation technique; Implant placement after Socket preservation Technique with sodium alderonate versus sticky bone in salama&salama Class 3 labial wall defect; Other Names: Implant in socket preserved with sodium alenderonate drug
Active Comparator: 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.	Procedure: Socket Preservation technique; Implant placement after Socket preservation Technique with sodium alderonate versus sticky bone in salama&salama Class 3 labial wall defect; Other Names: Implant in socket preserved with sodium alenderonate drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant stability	Calculate the final implant stability of two groups using Osstell "resonance frequency analyzer"	3-4 months after Dental implant placement

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
marginal bone	Evaluation of marginal bone resorption around implant in two groups using superimposition x-ray (CBCT) software analysis	3-4 months after Dental implant placement

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bone Density	Evaluation of bone density around the placed implants using x-ray (CBCT) software analysis	3-4 months after Dental implant placement

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Actual): May 23, 2021
• Study Completion (Anticipated): October 1, 2022

Study Registration Dates

• First Submitted: December 7, 2021
• First Submitted That Met QC Criteria: December 15, 2021
• First Posted (Actual): December 17, 2021

Study Record Updates

• Last Update Posted (Actual): December 17, 2021
• Last Update Submitted That Met QC Criteria: December 15, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Stability, Sodium Alendronate, Implant, Sticky bone
• Other Study ID Numbers: omfs335

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes