Assessment of Bone Quality After Socket Preservation Using Sodium Alendronate Gel Compared to Sticky Bone

NCT05771038 | Unknown Early Phase 1

• 1 other identifier: sodiumalendronate ,stickybone
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of study to evaluate the quality and quantity of the formed bone after socket preservation using sticky bone versus alendronate gel

Conditions

Bone Quality Assessment; Preserved Sockets; Sodium Alendronate; Sticky Bone

Outcome Measures

Primary Outcomes (1)

• Histomorphometric analysis

  bone sample will be taken and bone quality will be assesed

  3 month from the socket preservation procedure

Secondary Outcomes (2)

• Bone density

  3 month

• alveolar crest bone height

  3 month

Study Arms (2)

sodium alendronate group

ACTIVE COMPARATOR

prepared sodium alendronate gel will be placed in defective extraction sockets.

Procedure: socket preservation using sodium alendronate gel

stickybone group

ACTIVE COMPARATOR

20cc of venous blood is collected from the patient's forearm into silica-coated tube (10 ml) and 1 non coated vacutainer. Blood will be used to make injectable prf by spinning in centrifuge(2400-2700) for 2 minutes to produce autologous fibrin glue and then for 12 minutes+/- 2 minutes to obtain the concentrated growth factor layer. and sticky bone will be prepared then inserted into the socket.

Procedure: socket preservation using sticky bone

Interventions

socket preservation using sodium alendronate gel PROCEDURE

sockets will be preserved by sodium alendronate gel before then Patients will be evaluated after 3 days and weekly thereafter for the first month and then once monthly for signs of soft tissue irritation. After 3 months post-operative CBCT scans will be done to evaluate the bone density, alveolar crest bone height will be measured and core biopsy will be taken for Histomorphological study at the same visit where implant will be placed

sodium alendronate group

socket preservation using sticky bone PROCEDURE

sockets will be preserved by sticky bone as mentioned before then Patients will be evaluated after 3 days and weekly thereafter for the first month and then once monthly for signs of soft tissue irritation. After 3 months post-operative CBCT scans will be done to evaluate the bone density, alveolar crest bone height will be measured and core biopsy will be taken for Histomorphological study at the same visit where implant will be placed

stickybone group

Eligibility Criteria

• Age: 16 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \- defective class III sockets
• Patients with non-restorable teeth extracted sites
• Patients who have given their consent for this trial.
• Both genders males and females will be included.

You may not qualify if:

• Subjected to irradiation in the head and neck area less than 1 year before implantation.
• Patients having history of allergy to any drugs.
• Patients who have a history of any concomitant major known medical problem and/or ongoing pharmacologic treatments
• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Egypt

RECRUITING

Related Publications (1)

• Saulacic N, Munoz F, Kobayashi E, Chappuis V, Gonzales-Cantalapiedra A, Hofstetter W. Effects of local application of alendronate on early healing of extraction socket in dogs. Clin Oral Investig. 2020 Apr;24(4):1579-1589. doi: 10.1007/s00784-019-03031-7. Epub 2019 Jul 26.

  PMID: 31346723 BACKGROUND

Central Study Contacts

aya elgohary

CONTACT

00201100122225; aya.elgohary@dentistry.cu.edu.eg

mohammed omara

CONTACT

00201144452862

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: * In first group: 20cc of venous blood is collected from the patient's forearm into silica-coated tube (10 ml) and 1 non coated vacutainer. Blood will be used to make injectable prf by spinning in centrifuge(2400-2700) for 2 minutes to produce autologous fibrin glue and then for 12 minutes+/- 2 minutes to obtain the concentrated growth factor layer. and sticky bone will be prepared then inserted into the socket. * In second group: prepared sodium alendronate gel will be placed in defective extraction sockets.

Study Record Dates

• First Submitted: December 22, 2022
• First Posted: March 16, 2023
• Study Start: April 1, 2023
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: March 16, 2023

Record last verified: 2023-03

Locations

EG (1)