Trials / Active Not Recruiting

Active Not RecruitingNCT05748379

Atraumatic Zirconia Abutment Versus Customized Composite Healing Abutment in Maxilla or Mandible.

Closure of a Guided Immediate Implant Placed in the Extraction Socket With Bone Augmentation in the Lateral Area of the Maxilla or Mandible, With a Temporary Composite Abutment vs With a Custom-made Zirconium Oxide Abutment.

Status: Active Not Recruiting
Phase: N/A
Study type: Interventional
Enrollment: 44 (estimated)

Sponsor: SIA Adenta · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

40 patients are included in the study, 20 patients in group 1 (=closure with composite material shaper; test group) and 20 patients in group 2 (=closure with custom-made zirconia oxide abutment; control group). Randomisation envelopes will be used for randomisation. Device under study: Straumann BLX, Roxolid® , SLActive® dental implants with a diameter of 3.5, 3.75, 4, 4.5 mm are used. Allogenic bone botiss maxgraft® cortical granules are used as graft material. Inclusion criteria: 1. Males and females at least 18 years of age or older. 2. One implant per patient. 3. Prior to any study-related activity, the subject must voluntarily sign informed consent, be willing and able to attend scheduled follow-up visits, and agree to the collection and analysis of pseudonymised data. 4. Lateral individual teeth (premolars and molars). 5. Class I extraction socket (intact buccal wall) or class II (1/3 of buccal wall). 6. The gingival contour of the tooth to be extracted - without recession. 7. Adjacent anterior teeth have no periodontal loss. 8. There are no implants in the adjacent teeth. 9. Non-traumatic tooth extraction, which results in intact walls of the socket. Exclusion criteria: 1. Deep occlusion (severe, class II). 2. The patient smokes a lot (more than 10 cigarettes per day). 3. Systemic disease (osteoporosis). 4. No initial stability has been achieved after the implant insertion procedure.

Detailed description

General Notes 40 patients are included in the study, 20 patients in group 1 (=closure with composite material shaper; test group) and 20 patients in group 2 (=closure with custom-made zirconia oxide abutment; control group). Randomisation envelopes will be used for randomisation. Device under study: Straumann BLX, Roxolid® , SLActive® dental implants with a diameter of 3.5, 3.75, 4, 4.5 mm are used. Allogenic bone botiss maxgraft® cortical granules are used as graft material. Inclusion criteria: 1. Males and females at least 18 years of age or older. 2. One implant per patient. 3. Prior to any study-related activity, the subject must voluntarily sign informed consent, be willing and able to attend scheduled follow-up visits, and agree to the collection and analysis of pseudonymised data. 4. Lateral individual teeth (premolars and molars). 5. Class I extraction socket (intact buccal wall) or class II (1/3 of buccal wall). 6. The gingival contour of the tooth to be extracted - without recession. 7. Adjacent anterior teeth have no periodontal loss. 8. There are no implants in the adjacent teeth. 9. Non-traumatic tooth extraction, which results in intact walls of the socket. Exclusion criteria: 1. Deep occlusion (severe, class II). 2. The patient smokes a lot (more than 10 cigarettes per day). 3. Systemic disease (osteoporosis). 4. No initial stability has been achieved after the implant insertion procedure. 4.2. Surgical Procedures and Recovery Phase (see Annexes No. 1 and 2) Group 1. Immediate implant placement and temporary closure of tapered implants with a custom-made composite shaper after tooth extraction with bone augmentation by using allogeneic bone. 1. Non-traumatic extraction. 2. Palatal position of tapered implant for premolars and centred position for molars (more commonly - in the septum) 3-4 mm below the buccal gum line or 1-2 mm below the bony protuberance. 3. For premolars, the implant is placed palatally 2-3 mm to the buccal bone wall, for molars 2-3 mm to the buccal and lingual wall. 4. Implant insertion. 5. "Jump distance" sealing with allogeneic bone. 6. Temporary closure with a composite shaper. 7. Cone beam computed tomography with Carestream machine. 8. Taking a photo. 9. Scan with 3Shape TRIOS4 scanner. After 3 months, a cone beam computed tomography is performed to evaluate changes in the crestal bone, the temporary restoration is screwed off and the presence/absence of bleeding is recorded. A digital impression is taken for a zirconium oxide crown made on Ti base and to assess soft tissue changes. The change in the buccal vertical bone level will be measured as the difference between the former and the new vertical distance from implant platform to the buccal alveolar crest. While the change in the buccal horizontal bone dimension will be measured as the difference between the former and the new horizontal distance between the implant and the outer surface of the buccal plate. Both measurements will be taken using CBCT, one immediately after the surgery and the other one 3 month later. Intraoral scans with 3Shape Trios4 dental scanner will be taken to compare soft tissue stability. Measurements will be taken before, immediately after the surgery and 3 month later. By using STL files it will be possible to compare soft tissue stability. Group 2. Immediate implant placement and temporary closure of tapered implant with a custom-made zirconium oxide abutment after tooth extraction with bone augmentation by using allogeneic bone. 1. Non-traumatic extraction. 2. Palatal position of tapered implant for premolars and centred position for molars (more commonly - in the septum) 3-4 mm below the buccal gum line or 1-2 mm below the bony protuberance. 3. For premolars, the implant is placed palatally 2-3 mm to the buccal bone wall, for molars 2-3 mm to the buccal and lingual wall. 4. Implant insertion. 5. "Jump distance" sealing with allogeneic bone. 6. Closure with a zirconium oxide abutment. 7. Cone beam computed tomography with Carestream machine. 8. Taking a photo. 9. Scan with 3Shape TRIOS4 scanner. After 3 months, a cone beam computed tomography is performed to evaluate changes in the crestal bone, the custom-made abutment is screwed off and the presence/absence of bleeding is recorded. A digital impression is taken for a zirconium oxide crown and to assess soft tissue changes. The change in the buccal vertical bone level will be measured as the difference between the former and the new vertical distance from implant platform to the buccal alveolar crest. While the change in the buccal horizontal bone dimension will be measured as the difference between the former and the new horizontal distance between the implant and the outer surface of the buccal plate. Both measurements will be taken using CBCT, one immediately after the surgery and the other one 3 month later. Intraoral scans with 3Shape Trios4 dental scanner will be taken to compare soft tissue stability. Measurements will be taken before, immediately after the surgery and 3 month later. By using STL files it will be possible to compare soft tissue stability. Evaluation Phase T1 (Basic): After the performance of final restoration: X-ray, photograph, scan, PD, BOP, RI. T2: Follow-up after 3 months: X-ray, photograph, scan, PD, BOP, RI. T3: Follow-up after a year: X-ray, photograph, scan, PD, BOP, RI.

Conditions

Interventions

Type	Name	Description
PROCEDURE	Kompozite closure	Immediate implant placement and temporary closure of tapered implants with a custom-made composite shaper.
PROCEDURE	Individual abutment	Immediate implant placement and temporary closure of tapered implant with a custom-made zirconium oxide abutment.

Timeline

Start date: 2023-02-28
Primary completion: 2024-05-22
Completion: 2025-05-22
First posted: 2023-02-28
Last updated: 2025-05-14

Locations

1 site across 1 country: Latvia

Source: ClinicalTrials.gov record NCT05748379. Inclusion in this directory is not an endorsement.