Evaluation of Post-extraction Socket Preservation With Camelline Versus Bovine Deproteinized Xenograft

Socket Preservation Clinical Trial

Official title:

Evaluation of Post-extraction Socket Preservation With Camelline Versus Bovine Deproteinized Xenograft (Pilot Trial)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03677479
• Other study ID #: PER123
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: March 2019
• Est. completion date: August 2020

Study information

• Verified date: January 2019
• Source: Cairo University
• Contact: Ghada Adayil, Msc
• Phone: (+202)01006010412
• Email: ghada.adayil[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Alveolar ridge preservation following tooth extraction has the ability to maintain the ridge dimensions and allow the implant placement in an ideal position fulfilling both functional and aesthetic results. Postextraction socket healing commonly results in resorption of the alveolar ridge.

To prevent this clinical situation, different authors have described several surgical procedures, ranging from regenerative techniques for socket preservation to immediate implant placement. Regenerative techniques have been widely tested in controlled and uncontrolled studies with various materials and clinical approaches: bone grafting alone, including autografts, allografts, xenografts, and alloplasts; membrane alone, whether absorbable or not; and membrane in conjunction with grafting.

Description:

Various classic studies in the 1960s showed that the resorption process of the postextraction alveolus in both jaws was significantly more pronounced on the buccal aspect. This comes as no surprise, as the buccal surface of the anterior alveolar ridge is commonly thin and fragile. The maxilla tends to exhibit greater reductions in width than in height. The loss of tissue contour takes place mostly during the first 1 to 3 months following tooth extraction. Because the healing patterns of human sockets are unpredictable architecture), then such common procedures as extractions may lead to intraoral situations in which the remaining healed ridge does not allow for an esthetic and functional solution without the aid of significant bone grafting.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: August 2020
• Est. primary completion date: February 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Teeth with: root fractures, endodontic treatment failures, advanced caries lesions or any other cause that make tooth non-restorable and indicated for extraction.

• Healthy non-smoker patients

Exclusion Criteria:

• Medically compromised patients.

• Pregnant females.

• History of malignancy or radiotherapy/chemotherapy for malignancy in the past 5 years.

• History of active bone metabolic disease.

Related Conditions & MeSH terms

• Socket Preservation

Intervention

Procedure:
• socket preservation procedure
socket preservation of post extraction site using bone xenografts

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & Publications (1)

Chang PC, Chang HC, Lin TC, Tai WC. Preclinical alveolar ridge preservation using small-sized particles of bone replacement graft in combination with a gelatin cryogel scaffold. J Periodontol. 2018 Oct;89(10):1221-1229. doi: 10.1002/JPER.17-0629. Epub 201 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	patient-reported outcome	assessment of post-operative complication( pain, swelling, bleeding, infection)	within first week postoperatively
Secondary	ridge contour changes	dimentional changes after extraction and socket preservation	3 month, 6 month