The Effect of Concave Healing Abutment on Soft Tissue Healing

NCT05975814 | Unknown

• 1 other identifier: MIS-CONCAVE
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Implant Therapy

Keywords

dental implants; concave abutments; intra-oral scans; CBCT; soft tissue thickness; randomized clinical study

Outcome Measures

Primary Outcomes (1)

• Thickness of the peri-implant gingiva at the level of the largest mismatch between the straight and the concave abutment

  The thickness of the gingiva will be measured on the superposition set including the STL of the abutments on the vestibular and lingual/palatal sides

  end of healing, 6-8 weeks after implant surgery

Secondary Outcomes (1)

• Height of the peri-implant gingiva at the level of the largest mismatch between the straight and the concave abutment

  end of healing, 6-8 weeks after implant surgery

Study Arms (1)

concave abutment vs. straight abutment

EXPERIMENTAL

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.

Device: dental implant

Interventions

dental implant 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.

concave abutment vs. straight abutment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• MIS Implant Technologies, Ltd: lead
• Charite University, Berlin, Germany: collaborator
• Sachsen Praxen Zahnarztpraxis: collaborator

Study Sites (1)

Mis Implants Technologies Ltd.

Misgav Regional Council, 2015600, Israel

RECRUITING

Related Publications (1)

• 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.

  PMID: 34551159 RESULT

MeSH Terms

Interventions

Dental Implants

Intervention Hierarchy (Ancestors)

Dental Materials; Biomedical and Dental Materials; Dental Prosthesis; Prosthodontics; Dentistry; Prostheses and Implants; Equipment and Supplies; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Rasmus Sperber, Dr

  Sachen Praxen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thilo Damaskos, Dr

CONTACT

+41 170 228 2816; thilo.damaskos@gmx.de

Rasmus Sperber, Dr

CONTACT

+49 1511 6164966; rasmus.sperber@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: each implant receives either a straight or a concave abutment. The patient is not aware of the type of abutment.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: clinical study

Study Record Dates

• First Submitted: July 27, 2023
• First Posted: August 4, 2023
• Study Start: April 1, 2021
• Primary Completion: September 1, 2024
• Study Completion: January 1, 2025
• Last Updated: August 4, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)