NCT05538715

Brief Summary

The aim of the present prospective randomized controlled study is to compare the clinical, radiological, micro-circulation, and histology of a novel, semi-thick, and conventional full-thickness mucoperiosteal flap technique during horizontal alveolar ridge augmentation.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Nov 2019

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 8, 2019

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 14, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

November 27, 2023

Status Verified

September 1, 2023

Enrollment Period

4.9 years

First QC Date

September 9, 2022

Last Update Submit

November 23, 2023

Conditions

Partial-edentulism

Keywords

guided surgeryxenogenic graftaugmentationsurface scanningLaser Speckle Contrast Imaging

Outcome Measures

Primary Outcomes (2)

  • Orovestibular ridge width

    On prealigned pre- and postoperative CBCT cross-sections, linear measurements were taken parallel to a reference base to determine the orovestibular width of the surgical area.

    6 months postoperatively

  • Dimensional change of keratinized Gingiva

    Pre-and postoperatively a surface scan is performed using a Planmeca Emerald intraroral scanner. The superimposition of the measurements was used to evaluate the soft tissue changes associated with the treatments in 3 dimension.

    6 months postoperatively

Secondary Outcomes (2)

  • Histomorphometrical analysis

    Following reentry 6 months after augmentation

  • Gingival blood flow measurement at the early wound healing phase

    Pre-operative and 1, 3, 5, 7, 10, 14, 21, 28 days and 2, 3, 4, 5 and 6 months after surgeries.

Study Arms (2)

Split-thickness group

EXPERIMENTAL

Following randomization, horizontal guided bone regeneration utilizing Bio-Oss (Geistlich, Wolhusen, Switzerland) and autogenous bone in combination with Bio-Gide membrane (Geistlich, Wolhusen, Switzerland). Surgery is performed with a split-thickness flap design in the posterior maxilla or mandible in partially edentolous patients.

Procedure: Split-thickness group

Full-thickness group

EXPERIMENTAL

Following randomization, horizontal guided bone regeneration utilizing Bio-Oss (Geistlich, Wolhusen, Switzerland) and autogenous bone in combination with Bio-Gide membrane (Geistlich, Wolhusen, Switzerland). Surgery is performed with a full-thickness flap design in the posterior maxilla or mandible in partially edentolous patients.

Procedure: Full-thickness group

Interventions

Split-thickness groupPROCEDURE

Following randomization, horizontal guided bone regeneration utilizing Bio-Oss (Geistlich, Wolhusen, Switzerland) and autogenous bone in combination with Bio-Gide membrane (Geistlich, Wolhusen, Switzerland). Surgery is performed with a split-thickness flap design in the posterior maxilla or mandible in partially edentolous patients.

Split-thickness group
Full-thickness groupPROCEDURE

Following randomization, horizontal guided bone regeneration utilizing Bio-Oss (Geistlich, Wolhusen, Switzerland) and autogenous bone in combination with Bio-Gide membrane (Geistlich, Wolhusen, Switzerland). Surgery is performed with a full-thickness flap design in the posterior maxilla or mandible in partially edentolous patients.

Full-thickness group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • at least one edentulous maxillary/mandibulary premolar or molar site with horizontal bone loss
  • full- mouth plaque and bleeding scores (FMPS and FMBS) \<20%
  • good patient compliance (including willingness to participate in the follow-up procedures) signed informed consent-

You may not qualify if:

  • Active infectious diseases (HBV, HCV, HIV, TB, SARS CoV-2, etc.)
  • Current chemotherapy or radiotherapy
  • Radiation treatment of the former head and neck region (not older than 2 years)
  • Untreated insulin-dependent diabetes mellitus
  • Clinically significant osteoporosis or other systemic disease affecting bone metabolism
  • Clinically significant circulatory disorders such as decompensated cardiac failure
  • Haemodynamically significant heart failure or myocardial infarction within the last 3 months
  • Clinically significant coagulation disorder
  • Current or previous systemic corticosteroid therapy (not older than 2 months)
  • Current or previous systemic bisphosphonate therapy
  • Pregnant or breastfeeding mothers
  • Smoking
  • Drug addiction, alcoholism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Semmelweis University Department of Periodontology

Budapest, 1088, Hungary

RECRUITING

Related Publications (1)

  • Somodi K, Dobos A, Bartha F, Solyom E, Windisch P, Palkovics D, Molnar B. Changes in soft tissue dimensions following horizontal guided bone regeneration with a split-thickness flap design - evaluation of 8 cases with a digital method. Head Face Med. 2024 Sep 28;20(1):53. doi: 10.1186/s13005-024-00456-8.

    PMID: 39342334DERIVED

Central Study Contacts

Bálint Molnár, DMD, PhD

CONTACT

0036302553334molbal81@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants are not aware of the randomly assigned flap design. Independent examiners are not aware of patient allocation during analysis of clinical and radiographic data.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Test group: Following randomization, horizontal guided bone regeneration utilizing Bio-Oss (Geistlich, Wolhusen, Switzerland) and autogenous bone in combination with Bio-Gide membrane (Geistlich, Wolhusen, Switzerland). Surgery is performed with a full-thickness flap design in the posterior maxilla or mandible in partially edentolous patients. Control group: Following randomization, horizontal guided bone regeneration utilizing Bio-Oss (Geistlich, Wolhusen, Switzerland) and autogenous bone in combination with Bio-Gide membrane (Geistlich, Wolhusen, Switzerland). Surgery is performed with a split-thickness flap design in the posterior maxilla or mandible in partially edentolous patients.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2022

First Posted

September 14, 2022

Study Start

November 8, 2019

Primary Completion

September 30, 2024

Study Completion

September 30, 2024

Last Updated

November 27, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

HU(1)