The Effect of Concave Healing Abutment on Soft Tissue Healing

NCT ID: NCT05975814

Last Updated: 2023-08-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2025-01-01

Brief Summary

The aim of this study is to document the relevance of the concave abutment to form more gingiva when compared to the straight abutment.

Detailed Description

Standard clinical and radiographic examination will assess the need for implant therapy, the number of implants and the rehabilitation type. The pre-operative skeletal data will be observed with a 3D cone-beam computed tomographic examination (Cranex 3D, Soredex, Tuusula, Finland). On implantation day just before surgery, an initial intra-oral scan (TRIOS3, 3Shape, Copenhagen, Denmark) will be taken (IOS#0) to provide the baseline of the soft tissue outline. The surgical procedure will involve a crestal incision with 2 lateral discharge incisions; a full flap will be raised and the periosteum will be carefully separated from the cortical bone. The implant osteotomy will be prepared by executing the drilling sequence recommended by the manufacturer according to bone density; the final single-use drill that comes with each implant will be implemented on top of the drills when relevant. SEVEN (MIS) Ø 4.2 mm implants with an internal hex connection of appropriate length will be placed according to a 1-stage surgical protocol. They will receive a Ø 4.8 x 6 mm wide abutment, either straight or concave, according to the randomization. To anticipate early bone loss the implants will be seated slightly in a subcrestal position.

For single crown rehabilitations, a coin randomization will be performed to determine the abutment type, straight or concave; for plural restorations, randomization will start from the most distal implant. Height of all healing abutments will be 6 mm because this item provides the largest available mismatch concavity, 0.6 mm, compared to the straight abutment. After implant and abutment placement, the flap and periosteum will be reclined and sutured with single discontinued sutures around the abutments without tension. The patients will receive antibiotics (875/125 mg of Amoxicillin/Clavulanic acid, 3/d for 7 days; in case of penicillin allergy, 300 mg of Clindamycin every 6 h for 7 days) and analgesic anti-inflammatory treatment (600 mg Ibuprofen 3/d); rinsing with Chlorhexidine (0.12%) (Dentaid® PerioAid 0.12%) will be prescribed 2/d for 2 weeks. Sutures will be removed after 10 days (Cacaci et al., 2021). After a transmucosal soft tissue healing period of 6-8 weeks, the healed sites will be scanned (IOS#1).

Conditions

Dental Implant Therapy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

concave abutment vs. straight abutment

After implant is placed a randomization will determine if the implant receives a straight or a concave abutment. If a patient requires 2 implants, one of them will be straight and the other will be concave. A patient can therefore have both abutments.

Group Type: EXPERIMENTAL

dental implant

Intervention Type: DEVICE

dental implants are placed as usual and require a healing abutment. Abutments can be straight or concave, both are equally available on the market.

Interventions

dental implant

dental implants are placed as usual and require a healing abutment. Abutments can be straight or concave, both are equally available on the market.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

a) patients older than 18 years in need of implant therapy in the posterior area of the mandible and maxilla, b) good general/systemic health (ASA type I, II), c) patients who committed to attend all visits of the study, d) placement of a Ø 4.2 mm implant without requiring bone augmentation, e) adequate oral hygiene with FMPS (full mouth plaque score) < 15% before surgery, f) absence of uncontrolled periodontal disease, g) agreeing to sign an informed consent.

Exclusion Criteria

a) patients with a contributing medical history in which any surgery, disease, condition, or medication susceptible to compromise the healing of soft and hard tissues (e.g. non-controlled diabetes), b) liver function disorder, c) immune system disease, d) immunosuppressant drugs, e) toxic habits other than smoking that might compromise or affect healing, f) patients who have undergone chemotherapy or radiation treatment during the previous 5 years comprising the head and neck area, g) corticosteroids therapy or any other medication that could influence postoperative healing and/or osseointegration, h) bisphosphonate or Denosumab therapy (Prolia®), i) sites that underwent or require a horizontal or vertical bone regeneration procedure, j) inability or unwillingness to attend follow-up visits, k) patients unwilling to sign an informed consent form.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Charite University, Berlin, Germany

OTHER

Sponsor Role: collaborator

Sachsen Praxen Zahnarztpraxis

UNKNOWN

Sponsor Role: collaborator

MIS Implant Technologies, Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rasmus Sperber, Dr

Role: PRINCIPAL_INVESTIGATOR

Sachen Praxen

Locations

Mis Implants Technologies Ltd.

Misgav Regional Council, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Thilo Damaskos, Dr

Role: CONTACT

thilo.damaskos@gmx.de

+41 170 228 2816

Rasmus Sperber, Dr

Role: CONTACT

rasmus.sperber@gmail.com

+49 1511 6164966

Facility Contacts

Michal Malka

Role: primary

michal.malka@dentsplysirona.com

+972547257128

Serge Szmukler, Dr

Role: backup

serge.szmukler@dentsplysirona.com

+972537085454

References

Lilet R, Desiron M, Finelle G, Lecloux G, Seidel L, Lambert F. Immediate implant placement combining socket seal abutment and peri-implant socket filling: A prospective case series. Clin Oral Implants Res. 2022 Jan;33(1):33-44. doi: 10.1111/clr.13852. Epub 2021 Oct 22.

Reference Type: RESULT

PMID: 34551159 (View on PubMed)

Other Identifiers

MIS-CONCAVE

Identifier Type: -

Identifier Source: org_study_id