The Role of a New Prosthodontics Device in Hard and Soft Tissue Changes After Subcrestal Implant Placement

NCT06182670 | Completed DMC

• 1 other identifier: NABUT NP 4078
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The present randomized controlled trial aims to assess the influence of a new prosthodontics device (Gingival Former Abutment -GFA) on peri-implant bone loss and soft tissue changes and health after subcrestal oral implant placement. The participants will be divided in two groups and receive either crestal implant placement and traditional healing abutment or subcrestal implant placement and GFA. Clinical and radiographic examination will be performed at implant placement surgery, prosthetic load, 6 and 12 months follow-up.

Conditions

Edentulous Alveolar Ridge

Keywords

Oral Implants; Abutment; Subcrestal

Outcome Measures

Primary Outcomes (1)

• Change in Marginal Bone Level (MBL)

  The reabsorption of the bone measured through radiographically change on standardised radiographs. Baseline values will be compared to the values recorded in the follow-up visits.

  Surgery, 3, 9 and 15 months

Secondary Outcomes (4)

• Change in PD (periodontal depth) (implant site)

  3, 9 and 15 months

• Change in REC (Clinical Gingival Recession) (implant site)

  3, 9 and 15 months

• Change in BOP (Bleeding on Probing) (implant site)

  3, 9 and 15 months

• Change in PI (Plaque Index) (implant site)

  3, 9 and 15 months

Study Arms (2)

Subcrestal implant and gingival former abutment (GFA)

EXPERIMENTAL

The subjects receive a subcrestal implant and a prosthodontic device (GFA) immediately during the surgery. The GFA will not be removed upon prosthetic load. It will be an integral part of the prosthetic finalization.

Device: Gingival Former Abutment; Procedure: Subcrestal Implant; Device: Prosthetic Crown

Crestal implant and traditional abutment

ACTIVE COMPARATOR

The subjects receive a crestal implant and healing abutment. The healing abutment will be replaced by a definitive abutment to the prosthetic load.

Device: Healing Abutment; Device: Prosthetic Crown; Procedure: Crestal Implant

Interventions

Gingival Former Abutment DEVICE

GFA is positioned on the sub-crestal implant during the surgery and it is no longer removed. This follows the "one abutment one time" concept and should prevent bone loss and transmucosal tunnel.

Subcrestal implant and gingival former abutment (GFA)

Subcrestal Implant PROCEDURE

Placement of the endosseous sub-crestal dental implant through dedicated drills with 35 Newton insertion torque. It is positioned 2 mm under the crestal bone.

Subcrestal implant and gingival former abutment (GFA)

Healing Abutment DEVICE

A healing abutment is positioned on crestal implant during surgery. It is removed at prosthetic finalization.

Crestal implant and traditional abutment

Prosthetic Crown DEVICE

A zirconia prosthetic crown finalizes the implant rehabilitation.

Crestal implant and traditional abutment; Subcrestal implant and gingival former abutment (GFA)

Crestal Implant PROCEDURE

Placement of the endosseous crestal implant through dedicated drills with 35 Newton insertion torque at level of the alveolar bone.

Crestal implant and traditional abutment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to comprehend and sign informed consent.
• Male and female subjects, aged 18-75 years, inclusive.
• Good general health (free of systemic diseases such as diabetes, HIV infection or genetic disorder, ongoing malignant disease of any type that could influence the outcome of the treatment and might interfere with the evaluation of the study objectives).
• Good oral health (no decay, periapical or periodontal lesions, PI and BOP \<25%).
• Patient with posterior single missing tooth:
• for at least 5 months,
• mandibular or maxillary,
• intercalated (distance between teeth more than 7.5 mm),
• at least 11 mm of height residual bone (from bone crest to maxillary sinus or inferior alveolar nerve),
• at least 5 mm of bone width (buccal - palatal/lingual).
• Availability for the 12-month duration of the study.

You may not qualify if:

• Not willing to follow the agreed protocol.
• Presence of orthodontic appliances.
• Smokers more than 10 cigarettes per day.
• Chronic obstructive pulmonary disease and asthma.
• Tumors or significant pathology of the soft or hard tissues of the oral cavity.
• Current radiotherapy or chemotherapy.
• Pregnant or lactating women.
• Parafunctions like bruxism.
• Previous interventions to increase bone thickness in the implant area.
• Current or past assumption of medications that may influence surgical therapy and/or interfere with healing following surgical treatment.
• Systemic diseases that constitute a contraindication to surgical therapy and/or interfere with healing following surgical treatment.

Sponsors & Collaborators

• Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia: lead

Study Sites (1)

Magda Mensi

Brescia, Lombardy, 25123, Italy

Location

Study Officials

• Magda Mensi

  ASST Spedali Civili di Brescia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Monocentric, single blinded, randomized clinical trial, parallel design.

Study Record Dates

• First Submitted: December 10, 2023
• First Posted: December 27, 2023
• Study Start: June 6, 2021
• Primary Completion: June 7, 2023
• Study Completion: June 7, 2023
• Last Updated: December 27, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)