Alveolar Ridge Preservation Using Autogenous Tooth Graft Versus Autogenous Demineralized Dentin Graft.

Alveolar Ridge Preservation Clinical Trial

— ARP  

Official title:

Alveolar Ridge Preservation Using Autogenous Tooth Graft Versus Autogenous Demineralized Dentin Graft. A Randomized Controlled Clinical Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03447795
• Other study ID #: 19|01|02
• Status: Completed
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: June 1, 2020

Study information

• Verified date: November 2020
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Alveolar bone resorption following tooth extraction is unavoidable. Graft placement following extraction is recommended when considering restorative procedures afterwards. The extracted tooth was considered a clinical waste. However, it is now seen as a convenient and available source for graft material. Different protocols are applied to process the extracted tooth for obtaining the graft material and investigations are needed to assess the protocol with the best outcome.

Description:

Autogenous graft is widely accepted as the gold standard for grafting procedures(Sakkas et al. 2017). And since the introduction of autogenous dentin graft for alveolar ridge preservation by Kim et al. clinically (Y.-K. Kim et al. 2010), it has increasingly attracted attention and teeth are no longer seen only as a waste. Tooth dentin has a chemical composition similar to that of alveolar bone; the inorganic content is 70%-75%, organic content 20%, and water content 10%, whereas alveolar bone has proportions of 65%, 25%, and 10% respectively(Y.-K. Kim et al. 2013). The similarity in chemical composition between dentin and alveolar bone, as well as its content of growth factors such as bone morphogenetic proteins (BMPs), made the dentin a successful graft for filing alveolar bone defects of same patient(Y.-K. Kim et al. 2010, Nampo et al. 2010, Y.-K. Kim et al. 2013) .

The technique proposed by Kim et al includes demineralization of the dentin as it reduces minerals content, exposes collagen fibrils and increases BMPs released thus promoting the process of osteogenesis(Y.-K. Kim et al. 2010). However, demineralisation step is time-consuming, taking several days, which challenges same visit application. As a result, two main approaches have been developed to overcome this obstacle. One approach is to maintain the demineralization step but with improving the technique to shorten the processing time(MURATA et al. 2010, E.-S. Kim 2015, Kabir et al. 2015). On the other hand, many investigators have used the whole tooth without demineralization and reported satisfactory clinical outcome(Gideon Hallel et al. 2014, Valdec et al. 2017). Hence, more investigations are needed to evaluate the technique with the best outcome.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with non-restorable non-molar teeth

• Patients > 18 years old

• Motivated patients who are willing to continue the follow-up period

Exclusion Criteria:

• Compromised alveolar socket that is not contained to support graft material

• smokers and alcoholic patients.

• Patients with systemic conditions that may compromise hard tissue healing (i.e. poorly controlled diabetes, autoimmune diseases).

• Local infection at the site of extraction.

• Teeth with root canal filling.

Related Conditions & MeSH terms

• Alveolar Ridge Preservation
• Autogenous Tooth Bone Graft
• Dentin Graft

Intervention

Procedure:
• Alveolar ridge preservation
grafting procedure using autogenous tooth.

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cone beam computed tomography (CBCT) analysis	CBCT scans will be taken at first day and at 6 months after the grafting procedures. The scans will be compared using predetermined reference points, buccolingual and vertical dimensions will be measured in cross-sectional images using the same reference points and lines. The difference in mm will be subtracted.	immediately and after 6 months of grafting
Secondary	Histological analysis	Bone samples from at least one control and one intervention site will be taken during implant placement. Patients will be asked to sign and additional informed consent. A trephine bur will be used to obtain samples and then sent to the department of oral histology for assessment	after 6 months of grafting