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

R

Rambam Health Care Campus

Status

Completed

Conditions

Bio-Oss; Mucograft

Treatments

Device: Geistlich Bio-Oss® Collagen and Geistlich Mucograft® Seal

Study type

Interventional

Funder types

Other

Identifiers

NCT03395145
0507-17-RMB CTIL

Details and patient eligibility

About

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

Full 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.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

30 participants in 2 patient groups

Bio-Oss Collagen and Mucograft Seal
Experimental group
Description:
Bone volume Changes after socket preservation using Geistlich Bio-Oss® Collagen and Geistlich Mucograft® Seal
Treatment:
Device: Geistlich Bio-Oss® Collagen and Geistlich Mucograft® Seal
Natural healing
No Intervention group
Description:
Evaluation of Bone volume Changes after tooth extraction (natural healing)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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