Socket Preservation Using Biodentin Versus Xeno Graft for Single Rooted Teeth

NCT06695208 | Recruiting Phase 4

• 1 other identifier: CEBD_CU_2024-01-26
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Socket Perservation

Outcome Measures

Primary Outcomes (1)

• radiographic assessment to calculate bone width in millimeters after socket preservation in mandibular single rooted teeth using cone beam computed tomography

  calculation of bone width gain in millimeters in extraction socket in mandibular single rooted teeth using cone beam computed tomography.

  6 months postoperative

Secondary Outcomes (1)

• Histomorphometric analysis of bone after socket preservation in mandibular single rooted teeth harvested by trephine bur

  6 months postoperative

Study Arms (2)

biodentine group

EXPERIMENTAL

Drug: Biodentine

xeno graft group

ACTIVE COMPARATOR

Drug: Biodentine

Interventions

Biodentine DRUG

biodentine used in socket preservation

biodentine group; xeno graft group

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo university

Giza, Egypt

RECRUITING

Related Publications (7)

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

Related Links

• Lateral Alveolar Ridge Augmentation with Autogenous Tooth Block Graft Compared with Autogenous Bone Block Graft: a Systematic Review
• Tooth loss and oral health-related quality of life: a systematic review and meta-analysis
• Tooth loss and implant replacement
• Clinical Outcomes of Socket Preservation Using Bovine-Derived Xenograft Collagen and Collagen Membrane Post-Tooth Extraction: A 6-Month Randomized Controlled Clinical Trial
• Preservation of alveolar bone in extraction sockets using bioabsorbable membranes
• Biodentine™ material characteristics and clinical applications: a 3 year literature review and update
• Bone healing and soft tissue contour changes following single-tooth extraction: a clinical and radiographic 12-month prospective study

MeSH Terms

Interventions

tricalcium silicate

Central Study Contacts

maxim gerges, MSc

CONTACT

+201011466614; maxim.gerges@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: researcher

Study Record Dates

• First Submitted: November 8, 2024
• First Posted: November 19, 2024
• Study Start: December 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 19, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)