Clinical trial NCT03045458: Associations of Alveolar Bone Loss and Interleukin-1β Levels in One and Two Stage Surgical Procedures
Official title: Associations of Alveolar Bone Loss, Clinical Parameters and Interleukin-1β Levels in One and Two Stage Surgical Procedures: A Randomized Prospective Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Implant Infection
Alveolar Bone Loss
Keywords: one stage dental implant
two stage dental implant
Interleukin-1β
Lead sponsor: Firat University
Sponsor class: OTHER
Collaborators: name: Dicle University
First posted: 2017-02-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: OTHER

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.

Detailed description: The present study included 40 healthy patients (24 males and 16 females; mean age, 30.75 ± 8.58 years) who had one tooth absent in the mandible, at the Department of Periodontology, Dicle University, Diyarbakir, Turkey, between 2010 and 2011. All patients were informed in detail about the study protocol, and they were asked to sign informed consent forms. Ethics committee approval was obtained from Dicle University Ethics Committee for this study (D.Ü.D.F.E.K.2010/02)

This study was designed as a prospective, randomized, controlled study. Randomization was performed prior to surgery by opening a sequentially numbered sealed envelope corresponding to the patient recruitment number. Investigators received randomization instructions only after enrolling a subject and immediately prior to surgery. The participants were randomly divided into two groups. A one-stage surgical procedure was performed on 20 patients (Group I) and a two-stage surgical procedure was performed on the other 20 patients (Group II). The primary outcome of the study was a change in alveolar bone level at the implant site between T0 and T2 months after surgery measured on CBCT. The secondary outcomes between T0, T1, and T2 were changes the level of IL-1β PICF, probing pocket depth (PPD), modified plaque index (mPI), modified gingival index (mGI), and modified bleeding index (mBI). All implants (Straumann AG, Waldenburg, Switzerland) were inserted by the same periodontist (T.T.Y.) in the present study. Pre-surgical radiographic evaluation was conducted using CBCT. Before surgery, the patient's mouth was rinsed with chlorhexidine mouthwash. 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 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. 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. Patients of both groups were enrolled in a monthly periodontal/peri-implant maintenance program after abutments were connected in which, full mouth scaling was performed around all natural teeth and implant surfaces. Oral hygiene instructions regarding regular tooth brushing were given and patients were encouraged to floss the teeth and periimplant surfaces daily. There was no implant failed during the study and adverse event of these treatments.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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.

Primary outcomes:
measure: change of alveolar bone level
timeFrame: 0 and 6 month
Secondary outcomes:
measure: changes level of IL-1β
timeFrame: 0, 3, and 6 month
measure: changes of PPD
timeFrame: 0, 3, and 6 month
measure: changes of Modified plaque index
timeFrame: 0, 3, and 6 month
measure: changes of Modified gingival index
timeFrame: 0, 3, and 6 month
measure: changes of Modified bleeding index
timeFrame: 0, 3, and 6 month
Other outcomes:
Locations:
city: Diyarbakir
country: Turkey
facility: Dicle University
Study officials:
affiliation: Dicle University
name: tuba talo yıldırım
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.