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Recruiting NCT06695208

Socket Preservation Using Biodentin Versus Xeno Graft for Single Rooted Teeth

Phase IV Interventional Socket Perservation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Biodentine.
Who it may be relevant to
Registry conditions: Socket Perservation. Basic parameters: 25 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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

Overview

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

Interventions

  • Drug Biodentine
    biodentine used in socket preservation

Primary outcome measures

  • radiographic assessment to calculate bone width in millimeters after socket preservation in mandibular single rooted teeth using cone beam computed tomography [Time frame: 6 months postoperative]
Secondary outcome measures (1)
  • Histomorphometric analysis of bone after socket preservation in mandibular single rooted teeth harvested by trephine bur [Time frame: 6 months postoperative]

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Cairo university — Giza

Publications

  • 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. PMID 35574210
  • 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. PMID 21050499
  • 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. PMID 11062933
  • 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. PMID 28817143
  • 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. PMID 9776033
  • 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. PMID 29372451
  • 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. PMID 12956475

Identifiers

NCT: NCT06695208 · CEBD_CU_2024-01-26

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗