CClinicalTrials.gg
Status unknownNCT05162885Updated Dec 17, 2021

Effect of Sodium Alendronate on the Final Implant Stability.

An Early Phase 1 interventional study of Socket Preservation technique in Anterior Labial Wall Defect, sponsored by Cairo University. Status unknown at 1 site in Egypt. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-12-17.

Sponsored by Cairo University · Early Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2021), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled May 2021, registered Dec 2021).
Phase
Early Phase 1
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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

02

Conditions studied

  • Anterior Labial Wall Defect

Keywords

  • Stability, Sodium Alendronate, Implant, Sticky bone
03

In context

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
24 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • ProcedureSocket Preservation technique

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

    Also known as: Implant in socket preserved with sodium alenderonate drug

06

What researchers measure

Primary outcomes

  1. Implant stability

    Calculate the final implant stability of two groups using Osstell "resonance frequency analyzer"

    Time frame: 3-4 months after Dental implant placement

Secondary outcomes

  1. marginal bone

    Evaluation of marginal bone resorption around implant in two groups using superimposition x-ray (CBCT) software analysis

    Time frame: 3-4 months after Dental implant placement

Other outcomes

  1. Bone Density

    Evaluation of bone density around the placed implants using x-ray (CBCT) software analysis

    Time frame: 3-4 months after Dental implant placement

07

Study locations

1 of 1 sites recruiting
  • Hossam Abdallah Mohammed Ghazally
    Cairo, Manial 11553, Egypt
    • Nadia Galal Galal, PHD · Contact · Nadia.Galal@dentistry.cu.edu.eg · 01002177637
    • Nadia Galal Galal, PHD · Principal investigator
    • Mohammad Mohammed Omara, PHD · Sub investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 17, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05162885
Lead sponsor
Cairo University
Responsible party
Hossam Abdallah Mohammed Ghazzaly (H.Ghazzaly, Cairo University) — Principal investigator
First posted
Dec 17, 2021
Start date
May 1, 2021
Primary completion
May 23, 2021
Completion
Oct 1, 2022 (estimated)
Last update
Dec 17, 2021

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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