Bone Volume Changes After Socket Preservation Using Geistlich Bio-Oss Collagen and Mucograft Seal

Valuation of Bone Volume Changes After Socket Preservation Using Geistlich Bio-Oss® Collagen and Geistlich Mucograft® Seal Compared to Natural Healing After Tooth Extraction

Evaluation of Bone volume Changes after socket preservation using Geistlich Bio-Oss® Collagen and Geistlich Mucograft® Seal compared to natural healing after tooth extraction

Study Overview

• Status: Completed
• Conditions: Bio-Oss; Mucograft
• Intervention / Treatment: Device: Geistlich Bio-Oss® Collagen and Geistlich Mucograft® Seal

Detailed Description

In the last decade dental implants have become widely used for oral rehabilitation. But, the usage of dental Implants might be difficult in cases of alveolar bone deficiencies.

Different ridge preservation techniques were successfully used, using membrane with or without bone substitutes.new grafting material is Mucograft Seal, a collagen matrix graft, which originally used as an alternative to the connective tissue graft for the treatment of gingival recessions. Mucograft has demonstrated a good tissue reaction with high biocompatibility and a low shrinkage tendency, in order to increase the amount of keratinized gingiva in the augmented area.

Study Hypothesis: The observed changes in ridge dimensions when using Geistlich Bio-Oss® Collagen and Geistlich Mucograft® Seal as ridge preservation will be less pronounced in comparison to natural healing after tooth extraction.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eran Gabay, DMD; Phone Number: 7771636; Email: eran.gabay@mail.huji.ac.il

Study Locations

• Israel
  • Haifa, Israel, 31096
    • Rambam Health Care Campus, Dept. of Periodontology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Written informed consent.
• Patients of 18 years or older.
• Patients in need of a tooth extraction in the area of premolars, canines or incisors due to periodontal and/or dental reasons, provided that the socket walls are intact (bone dehiscence of max. 4mm limited to one bone wall).
• Patients who need implant placement at the site of extraction.

Exclusion Criteria:

• Inability to complete or understand the informed consent process.
• Bone dehiscence at extraction socket of more than 4 mm or 4 mm at more than one bony wall.
• Pregnant or lactating women.
• Patients who use medications that affect bone metabolism such as IV bisphosphonates.
• Heavy smokers (more than 10 cigarettes per day).
• Patients with removable prosthesis, which might compress the treated site.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bio-Oss Collagen and Mucograft Seal; Bone volume Changes after socket preservation using Geistlich Bio-Oss® Collagen and Geistlich Mucograft® Seal	Device: Geistlich Bio-Oss® Collagen and Geistlich Mucograft® Seal; Geistlich Bio-Oss® Collagen is intended to be used for filling bone defects and for bone augmentation after tooth extraction
No Intervention: Natural healing; Evaluation of Bone volume Changes after tooth extraction (natural healing)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
socket width mm	The socket width (buccal-lingual aspect) will be assessed at the following reference points: 3-(∆ACH pre-post) millimeters apical to the alveolar crest, where the buccal and lingual walls are intact.; 5-(∆ACH pre-post) millimeters apical to the alveolar crest, where the buccal and lingual walls are intact.; The width of each cortical buccal and lingual bone plate, 3 millimeters apical to the alveolar crest.; The width of each cortical buccal and lingual bone plate, 5 millimeters apical to the alveolar crest.	baseline (prior to tooth extraction) and 6 months (implant placement) and at 21 month (one year after loading
alveolar height mm	Alveolar crest height (ACH) will be measured from the apical part of the stent to the bone crest at the mid M-D distance of the socket.	baseline (prior to tooth extraction) and 6 months (implant placement) and at 21 month (one year after loading
keratinized tissue mm	In the lower jaw the keratinized tissue width will be measured from the apical part of the stent to the mucogingival line on the buccal and lingual sides. On the upper jaw only the keratinized tissue on the buccal side will be measured.	baseline (prior to tooth extraction) and 6 months (implant placement) and at 21 month (one year after loading

Collaborators and Investigators

• Sponsor: Rambam Health Care Campus

Study record dates

Study Major Dates

• Study Start (Actual): May 27, 2018
• Primary Completion (Actual): July 17, 2022
• Study Completion (Actual): July 17, 2022

Study Registration Dates

• First Submitted: January 1, 2018
• First Submitted That Met QC Criteria: January 9, 2018
• First Posted (Actual): January 10, 2018

Study Record Updates

• Last Update Posted (Actual): April 4, 2023
• Last Update Submitted That Met QC Criteria: April 2, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 0507-17-RMB CTIL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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