Clinical trial NCT06695208: Socket Preservation Using Biodentin Versus Xeno Graft for Single Rooted Teeth
Official title: Histomorphometric and Radiographic Assessment of Bone After Socket Preservation Using Biodentin Versus Xeno Graft for Socket Preservation of Single Rooted Mandibular Teeth: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Socket Perservation
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-11-19
Enrollment: 11
Sex: ALL
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: socket preservation using biodentin versus xeno graft for single rooted mandibular teeth

Detailed description: after extraction of single rooted mandibular teeth the socket will be filled with xeno graft or biodentine and the socket will be closed using gel foam and sutures then CBCT will be taken to measure bone width after 6 months of healing CBCT will be taken again to measure the difference in bone width and a core biopsy will be taken followed by implant placement

Eligibility criteria: Inclusion Criteria:

* Patients of both sex with badly decayed tooth indicated for extraction
* The ages of the patients ranged from 25 to 50 years.
* Patients with healthy systemic condition (Medically free)
* Adequate inter-arch space for placement of the implant prosthetic part.
* Good oral hygiene
* Cooperative patients who are willing to commit for 6 months follow up

Exclusion Criteria:

* Subjected to irradiation in the head and neck area less than 1 year before implantation.
* Poor oral hygiene and motivation.
* Smokers
* Patient with medical condition that contraindicates surgical procedures
* Pregnant or nursing.
* Substance abuse.
* Patients with habits that may jeopardize the implant longevity and affect the results of the study such as alcoholism or parafunctional habits severe bruxism or clenching.
* Active infection or severe inflammation in the area intended for implant placement.
* Patients on medication that may interfere with healing (corticosteroids, bisphosphonate, Chemo/radio therapy).

Primary outcomes:
measure: radiographic assessment to calculate bone width in millimeters after socket preservation in mandibular single rooted teeth using cone beam computed tomography
timeFrame: 6 months postoperative
Secondary outcomes:
measure: Histomorphometric analysis of bone after socket preservation in mandibular single rooted teeth harvested by trephine bur
timeFrame: 6 months postoperative
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Cairo university
Study officials:
References:
citation: Starch-Jensen T, Vitenson J, Deluiz D, Ostergaard KB, Tinoco EMB. Lateral Alveolar Ridge Augmentation with Autogenous Tooth Block Graft Compared with Autogenous Bone Block Graft: a Systematic Review. J Oral Maxillofac Res. 2022 Mar 31;13(1):e1. doi: 10.5037/jomr.2022.13101. eCollection 2022 Jan-Mar.
citation: Gerritsen AE, Allen PF, Witter DJ, Bronkhorst EM, Creugers NH. Tooth loss and oral health-related quality of life: a systematic review and meta-analysis. Health Qual Life Outcomes. 2010 Nov 5;8:126. doi: 10.1186/1477-7525-8-126.
citation: Henry PJ. Tooth loss and implant replacement. Aust Dent J. 2000 Sep;45(3):150-72. doi: 10.1111/j.1834-7819.2000.tb00552.x.
citation: Iorio-Siciliano V, Blasi A, Nicolo M, Iorio-Siciliano A, Riccitiello F, Ramaglia L. Clinical Outcomes of Socket Preservation Using Bovine-Derived Xenograft Collagen and Collagen Membrane Post-Tooth Extraction: A 6-Month Randomized Controlled Clinical Trial. Int J Periodontics Restorative Dent. 2017 Sep/Oct;37(5):e290-e296. doi: 10.11607/prd.2474.
citation: Lekovic V, Camargo PM, Klokkevold PR, Weinlaender M, Kenney EB, Dimitrijevic B, Nedic M. Preservation of alveolar bone in extraction sockets using bioabsorbable membranes. J Periodontol. 1998 Sep;69(9):1044-9. doi: 10.1902/jop.1998.69.9.1044.
citation: Rajasekharan S, Martens LC, Cauwels RGEC, Anthonappa RP. Biodentine material characteristics and clinical applications: a 3 year literature review and update. Eur Arch Paediatr Dent. 2018 Feb;19(1):1-22. doi: 10.1007/s40368-018-0328-x. Epub 2018 Jan 25.
citation: Schropp L, Wenzel A, Kostopoulos L, Karring T. Bone healing and soft tissue contour changes following single-tooth extraction: a clinical and radiographic 12-month prospective study. Int J Periodontics Restorative Dent. 2003 Aug;23(4):313-23.