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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-28

Study Completion Date

2025-05-22

Brief Summary

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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.

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Detailed Description

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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

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Dental Implants Humans Dental Implants, Single-Tooth Male Female Osseointegration Dental Anxiety Guided Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Each patient has their individual ID number

Study Groups

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Kompozite closure

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.

Group Type OTHER

Kompozite closure

Intervention Type PROCEDURE

Immediate implant placement and temporary closure of tapered implants with a custom-made composite shaper.

Individual abutment

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.

Group Type OTHER

Individual abutment

Intervention Type PROCEDURE

Immediate implant placement and temporary closure of tapered implant with a custom-made zirconium oxide abutment.

Interventions

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Kompozite closure

Immediate implant placement and temporary closure of tapered implants with a custom-made composite shaper.

Intervention Type PROCEDURE

Individual abutment

Immediate implant placement and temporary closure of tapered implant with a custom-made zirconium oxide abutment.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No