Clinical trial NCT03677479: Evaluation of Post-extraction Socket Preservation With Camelline Versus Bovine Deproteinized Xenograft
Official title: Evaluation of Post-extraction Socket Preservation With Camelline Versus Bovine Deproteinized Xenograft (Pilot Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Socket Preservation
Keywords: bone grafts
xenograft
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-09-19
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: pilot randomized clinical trial
Primary purpose: OTHER

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: patient-reported outcome
timeFrame: within first week postoperatively
Secondary outcomes:
measure: ridge contour changes
timeFrame: 3 month, 6 month
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Manal Hosny, PhD
role: STUDY_CHAIR
References:
citation: 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 2018 Aug 29.