Bioactive Glass (Sol-gel) for Alveolar Bone Regeneration After Surgical Extraction

NCT01878084 | Completed Results DMC

• 1 other identifier: BIOGLASS-STDF#116
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the present research is to evaluate the effect of bioactive glass in bone regeneration immediately following extraction of mandibular and maxillary premolars.The hypothesis of the study assumes that this treatment would promote the healing of the extraction socket while preserving both the height and width of the bone. Furthermore, it would allow more effective tooth movement during orthodontic treatment.

Conditions

Bone Loss; Vertical Alveolar Bone Loss; Horizontal Alveolar Bone Loss

Keywords

Tissue regeneration; sol gel bioglass; alveolar ridge preservation; children; Egyptian; class II orthodontic cases

Outcome Measures

Primary Outcomes (2)

• Change in Alveolar Crestal Bone Height

  The primary objective of the study is to determine the effect of using bioactive glass in preservation of alveolar crestal height and width surgical sockets immediately after premolar extraction assessed at baseline, 1,2,4,8,12,24 weeks post-extraction, baseline ,4 and 12 weeks reported. This change was analyzed by subtracting the values of each interval from the baseline values.the positive values indicate that the alveolar crest is coronal to the cemento enaml junction (reference point) , while the negative values indicate that the alveolar crest in apical to the cemento enamel junction (reference point)

  assessed at baseline, 1,2,4,8,12,24 weeks post-extraction, baseline,4 and 12 weeks reported.

• Bone Mineral Density

  The primary objective of the study is to determine the effect of using bioactive glass in inducing alveolar bone regeneration safely and effectively in surgical sockets immediately after premolar extraction assessed at baseline, 1,2,4,8,12,24 weeks post-extraction, baseline,4 and 12 weeks reported.

  assessed at baseline, 1,2,4,8,12,24 weeks post-extraction, baseline,4 and 12 weeks reported.

Study Arms (1)

all study participants

OTHER

This study represents a split-mouth study where the right or left/ upper or lower premolar could be assigned to either the control group (socket left empty) or test group (socket filled with bioactive glass (sol-gel) The extraction sockets will be allocated either to the control : Extraction socket will be left empty or Test: Extraction socket will be augmented using bioactive glass (sol-gel)

Other: bioactive glass (sol-gel); Other: empty extraction socket

Interventions

bioactive glass (sol-gel) OTHER

Extraction sockets will be augmented using bioactive glass (sol-gel)

Also known as: Tailored Amorphous Multiscale Porous (TAMP) scaffold

all study participants

empty extraction socket OTHER

Extraction socket will be left empty

all study participants

Eligibility Criteria

• Age: 9 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Patients must have good oral hygiene (confirmed by OHI-S)
• Patients who had voluntarily agreed on signing an informed consent including the duration and all the steps of the trial
• Patients who are indicated for the administration of the type of local anesthesia used in the trial
• Patients who need myofunctional therapy including premolar extraction as part of two stage treatment (class II division I)
• Patients indicated for premolar extraction as a normal step in the treatment plan not intentionally for the experiment.
• Patients who had undergone x- rays on the premolar teeth showing root form and the shape of the socket prior to extraction

You may not qualify if:

• Patients with history of bleeding disorders which will hinder the normal healing process of the needed sockets for the trial
• Patients with history of allergy to foreign bodies , i.e. susceptible to reactions from Bioglass
• Patients with history of hypertension and diabetes , rendering them not indicated for administration of the recommended type of local anesthesia nor even for extraction
• Patients having HCV , HBV , HIV or other infectious diseases to make sure of the safety of the research team and the participants from probable infection .
• Mentally retarded patients who are not able to understand the steps of the trial Patients with systemic diseases or febrile illness making them unable to follow the appointments arranged
• Patients who simultaneously participate in other research studies
• Patients with traumatic surgical extraction

Sponsors & Collaborators

• Alexandria University: lead
• Lehigh University: collaborator

Study Sites (1)

Tissue Engineering Laboratories, Faculty of Dentistry, Alexandria University

Alexandria, Egypt

Location

Related Publications (1)

• El Shazley N, Hamdy A, El-Eneen HA, El Backly RM, Saad MM, Essam W, Moussa H, El Tantawi M, Jain H, Marei MK. Bioglass in Alveolar Bone Regeneration in Orthodontic Patients: Randomized Controlled Clinical Trial. JDR Clin Trans Res. 2016 Oct;1(3):244-255. doi: 10.1177/2380084416660672. Epub 2016 Aug 6.

  PMID: 30931746 DERIVED

MeSH Terms

Conditions

Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Prof. Mona K. Marei
• Organization: Alexandria University

mona.marei@gmail.com

002-03-4858353

Study Officials

• Mona Marei, prof

  Alexandria University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor/head of tissue engineering laboratories, faculty of dentistry

Model Details: This study represents a split-mouth study where the right or left/ upper or lower premolar could be assigned to either the control group (socket left empty) or test group (socket filled with bioactive glass (sol-gel) The extraction sockets will be allocated either to the control : Extraction socket will be left empty or Test: Extraction socket will be augmented using bioactive glass (sol-gel)

Study Record Dates

• First Submitted: June 10, 2013
• First Posted: June 14, 2013
• Study Start: October 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: January 1, 2018
• Last Updated: February 18, 2020
• Results First Posted: February 18, 2020

Record last verified: 2020-02

Locations

EG (1)