Clinical trial NCT03395145: Bone Volume Changes After Socket Preservation Using Geistlich Bio-Oss Collagen and Mucograft Seal
Official title: Valuation of Bone Volume Changes After Socket Preservation Using Geistlich Bio-Oss® Collagen and Geistlich Mucograft® Seal Compared to Natural Healing After Tooth Extraction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bio-Oss; Mucograft
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2018-01-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: socket width mm
timeFrame: baseline (prior to tooth extraction) and 6 months (implant placement) and at 21 month (one year after loading
measure: alveolar height mm
timeFrame: baseline (prior to tooth extraction) and 6 months (implant placement) and at 21 month (one year after loading
measure: keratinized tissue mm
timeFrame: baseline (prior to tooth extraction) and 6 months (implant placement) and at 21 month (one year after loading
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Health Care Campus, Dept. of Periodontology
Study officials:
affiliation: Rambam Health Care Campus
name: Eli Machtei, DMD
role: PRINCIPAL_INVESTIGATOR
References: