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

Alveolar Bone Loss Clinical Trial

Official title:

Associations of Alveolar Bone Loss, Clinical Parameters and Interleukin-1β Levels in One and Two Stage Surgical Procedures: A Randomized Prospective Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03045458
• Other study ID #: D.Ü.D.F.E.K.2010/02
• Status: Completed
• Phase: N/A
• First received: January 25, 2017
• Last updated: February 6, 2017
• Start date: September 1, 2010
• Est. completion date: June 1, 2011

Study information

• Verified date: February 2017
• Source: Firat University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 1, 2011
• Est. primary completion date: October 1, 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alveolar Bone Loss
• Implant Infection

Intervention

Device:
• tissue level dental implant
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.
• Bone level dental implant
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.

Locations

Country	Name	City	State
Turkey	Dicle University	Diyarbakir

Sponsors (2)

Lead Sponsor	Collaborator
Firat University	Dicle University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	changes level of IL-1ß	The secondary outcome of the study was change the level of IL-1ß pg/ml between T0, T1, and T2. To obtain PICF, filter paper strips were gently inserted into the peri-implant crevice for 30 s at the mesial, distal, buccal, and lingual sites of the dental implant. A Williams periodontal probe was used for all clinical measurements.These parameters were recorded for evaluating the clinical status of the dental implants. All measurements were performed at four sites around each dental implant. For the statistical analysis, median of the four measurements at each implant was used.; The level of IL-1ß pg/ml (weight in picogram, weight in milliliter)	0, 3, and 6 month
Secondary	changes of PPD	The secondary outcome of the study was change of the PPD between T0, T1, and T2. A Williams periodontal probe was used for all clinical measurements.These parameters were recorded for evaluating the clinical status of the dental implants. All measurements were performed at four sites around each dental implant. For the statistical analysis, median of the four measurements at each implant was used.; Probing pocket depth (PPD) (depth in mm), were measured	0, 3, and 6 month
Secondary	changes of Modified plaque index	The secondary outcome of the study was change of the Modified plaque index between T0, T1, and T2. A Williams periodontal probe was used for all clinical measurements.These parameters were recorded for evaluating the clinical status of the dental implants. All measurements were performed at four sites around each dental implant. For the statistical analysis, median of the four measurements at each implant was used.; Modified plaque index (0=no plaque, 1= mild plaque, 2= moderate plaque, 3=severe plaque).	0, 3, and 6 month
Secondary	changes of Modified gingival index	The secondary outcome of the study was change of the Modified gingival index between T0, T1, and T2. A Williams periodontal probe was used for all clinical measurements.These parameters were recorded for evaluating the clinical status of the dental implants. All measurements were performed at four sites around each dental implant. For the statistical analysis, median of the four measurements at each implant was used.; Modified gingival index (0=healthy, 1=mild inflammation 2= moderate inflammation 3=severe inflammation).	0, 3, and 6 month
Secondary	changes of Modified bleeding index	The secondary outcome of the study was change of the Modified bleeding index between T0, T1, and T2. A Williams periodontal probe was used for all clinical measurements.These parameters were recorded for evaluating the clinical status of the dental implants. All measurements were performed at four sites around each dental implant. For the statistical analysis, median of the four measurements at each implant was used.; Modified bleeding index (0= no bleeding, 1= mild bleeding, 2= moderate bleeding, 3=severe bleeding).	0, 3, and 6 month