Using the Roots of a Non Restorable Wisdom Tooth as a Block for Augmentation of Localized Defects (Clinical)

The Effect of Autogenous Tooth Roots for Lateral Alveolar Ridge Augmentation and Staged Implant Placement (A Controlled Clinical Study With Histological Assessment)

assess and compare the efficacy and safety of autogenous tooth roots for lateral alveolar ridge augmentation with staged implant placement in comparison to autogenous bone block.

Study Overview

• Status: Unknown
• Conditions: Augmentation
• Intervention / Treatment: Procedure: autogenous bone block; Procedure: tooth block

Detailed Description

A total of 14 patients in need of implant therapy and lateral ridge augmentation were allocated to parallel groups receiving either 1) healthy autogenous tooth roots (e.g. retained wisdom or impacted teeth or 2) cortical autogenous bone blocks harvested from the retromolar area. After 26 weeks of submerged healing the horizontal bone gain were assessed both clinically and radiographically. A core biopsy was taken during the implant placement to assess the histology of the newly formed bone.

• Study Type: Interventional
• Enrollment (Anticipated): 14
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Abbassia
    • Cairo, Abbassia, Egypt, 11566
      • Recruiting
      • Ain Shams University
      • Contact: Laila El Raee, B.D.S; Phone Number: +201280967588; Email: lelraee@msa.eun.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Candidate for lateral ridge augmentation
2. Insufficient bone ridge width at the recipient site for implant placement
3. Sufficient bone height at the recipient site for implant placement
4. Healthy oral mucosa, at least 3 mm keratinized tissue.
5. Presence of wisdom teeth free from periapical infection.
6. Missing maxillary or mandibular tooth with moderate horizontal defect (4-8) according to cologne classification

Exclusion Criteria:

• 1) Patients are systemically free according to Modified Cornell Medical Index 2) smokers patients. 3) Pregnant or lactating women.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Autogenous bone block; the monocortical block grafts were harvested from the retromolar region (i.e. linea oblique) by using of rotating (i.e. carbide burs)	Procedure: autogenous bone block; autogenous bone block were used to increase the bone width
Experimental: Tooth block; In the first group, a second mucoperiosteal flap was elevated to surgically remove the respective wisdom tooth. After its removal and during the same surgery, the crown was decapitated at the cemento -enamel junction using a rotating carbide bur under gentle sterile saline cooling and the exposed pulp was preserved. The separated tooth root was adapted to match the size and shape of the defect area. To improve ankylosis between the graft and the defect site, the layer of cementum at the respective downward aspects of the root was carefully removed using a diamond bur until the underlying dentin was entirely exposed	Procedure: tooth block; tooth root blocks were used to increase the bone width

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Clinical and radiographic assessment of alveolar bone width following autogenous tooth roots augmentation.	6 months postoperatively

Secondary Outcome Measures

Outcome Measure	Time Frame
Histological analysis of remodeled autogenous bone roots 4 months following horizontal ridge augmentation. Histological analysis of remodeled autogenous bone roots 4 months following horizontal ridge augmentation.	6 months postoperatively

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2018
• Primary Completion (Anticipated): August 15, 2020
• Study Completion (Anticipated): September 30, 2020

Study Registration Dates

• First Submitted: January 29, 2020
• First Submitted That Met QC Criteria: February 11, 2020
• First Posted (Actual): February 12, 2020

Study Record Updates

• Last Update Posted (Actual): July 22, 2020
• Last Update Submitted That Met QC Criteria: July 21, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Dental implants; tooth block
• Other Study ID Numbers: 121734

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No