Effect of Sodium Alendronate on the Final Implant Stability.

Sponsor

Cairo University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05162885

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Anterior Labial Wall Defect	Procedure: Socket Preservation technique	Early Phase 1

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 Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 1, 2021

Actual Primary Completion Date :

May 23, 2021

Anticipated Study Completion Date :

Oct 1, 2022

Arms and Interventions

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

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

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

Outcome Measures

Primary Outcome Measures

Implant stability [3-4 months after Dental implant placement]
Calculate the final implant stability of two groups using Osstell "resonance frequency analyzer"

Secondary Outcome Measures

marginal bone [3-4 months after Dental implant placement]
Evaluation of marginal bone resorption around implant in two groups using superimposition x-ray (CBCT) software analysis

Other Outcome Measures

Bone Density [3-4 months after Dental implant placement]
Evaluation of bone density around the placed implants using x-ray (CBCT) software analysis

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hossam Abdallah Mohammed Ghazally	Cairo	Manial	Egypt	11553

Sponsors and Collaborators

Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hossam Abdallah Mohammed Ghazzaly, H.Ghazzaly, Cairo University

ClinicalTrials.gov Identifier:

NCT05162885

Other Study ID Numbers:

omfs335

First Posted:

Dec 17, 2021

Last Update Posted:

Dec 17, 2021

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

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

Keywords provided by Hossam Abdallah Mohammed Ghazzaly, H.Ghazzaly, Cairo University

Stability, Sodium Alendronate, Implant, Sticky bone

Study Results

No Results Posted as of Dec 17, 2021