Evaluation of Autogenous Demineralized Dentin Graft for Ridge Preservation With and Without Injectable Platelet Rich Fibrin

Alveolar Bone Loss Clinical Trial

Official title:

Clinical and Radiographic Evaluation of Autogenous Demineralized Dentin Graft for Ridge Preservation With and Without Injectable Platelet Rich Fibrin (A Randomized Controlled Clinical Trial)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05437172
• Other study ID #: Shaam
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 30, 2022
• Est. completion date: December 15, 2023

Study information

• Verified date: August 2023
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Ridge preservation should be considered whenever possible after tooth extraction. Whether implant placement would be performed or for aesthetic consideration at pontic sites when conventional bridge is planned. Ridge preservation aims to maximize the bone formation accompanied with good soft tissue architecture to facilitate implant and prosthetic replacement restoring function, phonetics and aesthetics. the Aim of the study is To evaluate the bucco-lingual ridge width clinically and radiographically, height of buccal and lingual ridges of the socket after application of injectable platelet rich fibrin and autogenous dentin graft.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. completion date: December 15, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years need of at least one single rooted tooth extraction.

• Non-restorable teeth.

• Systemically healthy patients.

• Good oral hygiene, Plaque index less than 15%.

• Non-smoker or Smoking = 10 cigarettes/day.

• Cooperative patients able and accept to come for follow up appointments.

Exclusion Criteria:

• Any interim intervention that may have affected any of the outcomes of interest.

• Pregnant and lactation females.

• Smoking ? 10 cigarettes/day.

• Patients reporting systemic conditions that may compromise healing or bone metabolism (eg: diabetes).

• Patients with poor oral hygiene.

• Any known allergies.

Related Conditions & MeSH terms

• Alveolar Bone Loss
• Dentin Graft
• Ridge Preservation

Intervention

Procedure:
• injectable platelet rich fibrin with demineralized dentin graft
after atraumatic extraction, collection of whole venous blood (9 ml) in sterile vacutainer tubes will be done without anticoagulant added, vacutainer tubes will be then placed in a centrifugal machine at 700 revolutions per minute (rpm) for 3 min with a tube filled with water to maintain the balance during the centrifuging process. ADDG particles prepared by demineralization of tooth particles in 0.6N hydrochloric acid for 30 min to achieve demineralization then washed twice in saline and dried with sterile gauze. Graft particles will be loaded at the defect site to restore ridge form, large metal condenser was used to adapt the graft to the defect and stabilizing the graft with sutures.
• demineralized dentin graft
after atraumatic extraction, ADDG particles will be prepared by demineralization of tooth particles in 0.6N hydrochloric acid for 30 min to achieve demineralization then washed twice in saline and dried with sterile gauze. Graft particles will be loaded at the defect site to restore ridge form, large metal condenser was used to adapt the graft to the defect and stabilizing the graft with sutures.

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Cairo University	Cairo	Manial

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiographic Bucco-lingual ridge width change	radiographic measurement	up to 24 weeks
Secondary	Changes in the height of the socket buccal and lingual ridges.	radiographic measurement	up to 24 weeks
Secondary	postoperative pain	Visual analogue scale from zero (better) to 10 (worse)	immediately after the procedure
Secondary	Patient satisfaction	binary yes and no	immediately after the procedure
Secondary	Keratinized tissue width	periodontal probe measurement	up to 24 weeks
Secondary	chair time	in minutes	immediately after the procedure