Associations of Alveolar Bone Loss and Interleukin-1β Levels in One and Two Stage Surgical Procedures

NCT03045458 | Completed FDA Device

• 1 other identifier: D.Ü.D.F.E.K.2010/02
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The present study was compared the level of alveolar bone loss, clinical parameters and IL-1β in PICF in one- or two-stage surgical procedures. Half of the patients were performed tissue level implant while other half were performed bone level implant.

Conditions

Implant Infection; Alveolar Bone Loss

Keywords

one stage dental implant; two stage dental implant; Interleukin-1β

Outcome Measures

Primary Outcomes (1)

• change of alveolar bone level

  The primary outcome of the study was a change in alveolar bone level (height in mm) at the 40 implant site between T0 and T2 months after surgery measured on CBCT. All measurements were performed at four sites (mesial, distal, buccal, and lingual) around each dental implant at T0 and T2. These four values were then averaged for each dental implant. * Alveolar bone level were measured in millimeters (height in mm) from a fixed reference point on the implant (implant shoulder to the most coronal position of the crestal bone contacting the implant).

  0 and 6 month

Secondary Outcomes (5)

• changes level of IL-1β

  0, 3, and 6 month

• changes of PPD

  0, 3, and 6 month

• changes of Modified plaque index

  0, 3, and 6 month

• changes of Modified gingival index

  0, 3, and 6 month

• changes of Modified bleeding index

  0, 3, and 6 month

Study Arms (2)

Tissue level dental implant

ACTIVE COMPARATOR

Tissue level dental implants (Straumann AG, Waldenburg, Switzerland) were inserted in patients group I (n=20).

Device: tissue level dental implant

Bone level dental implant

ACTIVE COMPARATOR

Bone level dental implants (Straumann AG, Waldenburg, Switzerland ) were inserted in patients group II (n=20).

Device: Bone level dental implant

Interventions

tissue level dental implant DEVICE

After local anesthesia, full thickness flaps were reflected, and osteotomies were prepared in the first mandibular molar sites. In these surgical operations, 20 tissue-level implants 12 mm in length and 4.8 mm in diameter were inserted in Group I. Cover screw was removed and replaced with healing abutments.

Also known as: Straumann AG, Waldenburg, Switzerland, dental implant

Tissue level dental implant

Bone level dental implant DEVICE

After local anesthesia, full thickness flaps were reflected, and osteotomies were prepared in the first mandibular molar sites. In these surgical operations, 20 bone-level dental implants 12 mm in length and 4.8 mm in diameter were inserted inGroup II. Three months later, second-stage surgery was performed and implant exposed into the oral cavity. Cover screw was removed and replaced with healing abutments. Three months waited for second surgery in bone level implants.

Also known as: Straumann AG, Waldenburg, Switzerland, dental implant

Bone level dental implant

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• patients in the study who had one tooth absent in the mandible
• patients in the study should be least 18 years old.

You may not qualify if:

• Patients in the study were the absence of the following points;
• poor mouth hygiene,
• bruxism, dental implants,
• chemotherapy or radiotherapy,
• addictions (alcohol, cigarettes, and medications),
• disease in the jawbones observed clinically or radiographically,
• pregnancy,
• antibiotic and/or anti-inflammatory medication use in the last three months.

Sponsors & Collaborators

• Firat University: lead
• Dicle University: collaborator

Study Sites (1)

Dicle University

Diyarbakır, Turkey (Türkiye)

Location

Related Publications (1)

• Talo Yildirim T, Acun Kaya F, Yokus B, Colak M, Ozdemir Kaya E, Tekin G, Saribas E, Uysal E, Guncu GN. Associations of alveolar bone loss and interleukin-1beta levels in one- and two-stage surgical procedures: a randomized prospective trial. Acta Odontol Scand. 2017 Nov;75(8):608-615. doi: 10.1080/00016357.2017.1367959. Epub 2017 Aug 21.

  PMID: 28826290 DERIVED

MeSH Terms

Conditions

Alveolar Bone Loss

Interventions

Dental Implants

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Materials; Biomedical and Dental Materials; Dental Prosthesis; Prosthodontics; Dentistry; Prostheses and Implants; Equipment and Supplies; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• tuba talo yıldırım

  Dicle University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Only the surgeon knows detail about the groups of participants. Participant, care provider,outcomes assessor have no knowledge of groups
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Model Details: In the surgical operations, 20 tissue-level and 20 bone-level dental implants 12 mm in length and 4.8 mm in diameter were inserted in Group I and Group II, respectively.

Study Record Dates

• First Submitted: January 25, 2017
• First Posted: February 7, 2017
• Study Start: September 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: June 1, 2011
• Last Updated: February 7, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)