Emdogain Implementation With Transcrestal Sinus Lifting and Dental Implant Placement

NCT05507047 | Completed Phase 4

• 1 other identifier: 14/4
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the clinical and radiographic results of implants placed using osteotome sinus floor elevation (OSFE) with and without simultaneous enamel matrix derivative (EMD) application.

Conditions

Osseointegration Failure of Dental Implant; Bone Density Increased

Keywords

enamel matrix derivated; maxillary sinus

Outcome Measures

Primary Outcomes (1)

• endo-sinus bone gain

  New bone formation into sinus (NB) following OSFE- measured by endo-sinus bone gain

  CBCT will be evaluated at initiation of study (T0), at 3th month (T1) and 12th month (T2)

Secondary Outcomes (5)

• radiographic measurements

  CBCT will be evaluated at initiation of study (T0), at 3th month (T1) and 12th month (T2)

• implant stability

  It will be measured at initiated at implant placement and third month follow-up

• Radiographic measurements

  CBCT will be evaluated at initiation of study (T0), and at 12th month (T2)

• peri-implant sinus bone level

  CBCT will be evaluated at initiation of study (T0), at 3th month (T1) and 12th month (T2)

• Densitometric Analysis

  Bone Density was measured at baseline, 3- and 12-months by CBCT scans

Study Arms (2)

Transcrestal Sinus Lifting with Emdogain

EXPERIMENTAL

Osteotome sinus floor elevation with enamel matrix derivated

Drug: Enamel Matrix Protein

Transcrestal Sinus Lifting

ACTIVE COMPARATOR

Osteotome sinus floor elevation

Drug: Enamel Matrix Protein

Interventions

Enamel Matrix Protein DRUG

Enamel matrix derivated is used with transcrestal sinus lifting treatment

Also known as: emdogain

Transcrestal Sinus Lifting; Transcrestal Sinus Lifting with Emdogain

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• partial edentulism in the maxillary posterior region for at least 4 months from tooth loss and require implant treatment
• adequate bone thickness for primary stabilization
• residual bone height ranged from 4 mm to 6 mm
• systemic and local conditions compatible with implant placement and sinus floor elevation
• antagonist teeth

You may not qualify if:

• uncontrolled diabetes mellitus or other systemic disorders (such as; hepatitis, tuberculosis, AIDS)
• pregnancy
• untreated periodontal disease
• endodontic lesions or other oral disorders
• heavy smokers (≥10 cigarettes per day)
• acute or chronic rhinitis
• sinusitis or pathology in sinus
• inadequate residual bone height and quality to achieve implant stability
• previous implant treatment/failure or bone augmentation in the implant site
• sinus perforation as confirmed via Valsalva maneuver
• insufficient primary implant stability measured by RFA

Sponsors & Collaborators

• T.C. Dumlupınar Üniversitesi: lead

Study Sites (1)

Gazi University Faculty of Dentistry

Ankara, 06100, Turkey (Türkiye)

Location

Related Publications (1)

• Vincent-Bugnas S, Charbit Y, Charbit M, Dard M, Pippenger B. Maxillary Sinus Floor Elevation Surgery With BioOss Mixed With Enamel Matrix Derivative: A Human Randomized Controlled Clinical and Histologic Study. J Oral Implantol. 2020 Oct 1;46(5):507-513. doi: 10.1563/aaid-joi-D-19-00119.

  PMID: 32299097 RESULT

Related Links

• Maxillary Sinus Floor Elevation Surgery With BioOss Mixed With Enamel Matrix Derivative
• Effect of enamel matrix derivative on alveolar ridge preservation in the posterior maxilla

MeSH Terms

Conditions

Osteosclerosis

Interventions

enamel matrix proteins

Condition Hierarchy (Ancestors)

Osteochondrodysplasias; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Deniz Ozbay, DDS PhD

  Gazi University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc Prof

Study Record Dates

• First Submitted: August 15, 2022
• First Posted: August 18, 2022
• Study Start: January 1, 2017
• Primary Completion: January 1, 2020
• Study Completion: December 1, 2020
• Last Updated: August 18, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)