Prosthetic Modality and MBL

NCT07156110 | Recruiting DMC

• 1 other identifier: L1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The present study will test the effect of different prosthetic modalities on conical and internal hex connection implants, assessing the radiographic MBL changes after one year. Consecutive patients fulfilling inclusion/exclusion criteria will enter the study. Once the implant is inserted, patients will be divided into three groups according to the time if their inclusion in the study. Study groups (20 patients per group):

1. 1.Group 1: Placing Lance Conical implant with a healing abutment. Three months later, after an impression, a screw-retained restoration will be seated using a Ti-Base abutment.
2. 2.Group 2: Placing Lance+ (Internal Hex connection) implant with a healing abutment. Three months later, after an impression, a screw-retained restoration will be seated using a Ti-Base abutment.
3. 3.Group 3: Placing Lance Conical implant together with Connect Abutment (tightened to 30 Ncm) with a Connect healing cap ("one time one abutment"). Screw retained restoration after 3 months.

Conditions

Bone Loss

Keywords

Marginal bone level changes; prosthetic modalities; soft tissue adaptation

Outcome Measures

Primary Outcomes (1)

• MBL

  magical bone level changes will be measured through X-rays

  one year post surgery

Secondary Outcomes (3)

• peri-implant soft tissue variables

  one year post surgery

• peri-implant soft tissue variables

  one year post surgery

• peri-implant soft tissue variables

  one year post surgery

Study Arms (3)

Arm 1

ACTIVE COMPARATOR

Placing Lance+ (Internal Hex connection) implant with a healing abutment. Three months later, after an impression, a screw-retained restoration will be seated using a Ti-Base abutment.

Procedure: Traditional prosthetic procedure

Arm 2

EXPERIMENTAL

Placing Lance Conical implant with a healing abutment. Three months later, after an impression, a screw-retained restoration will be seated using a Ti-Base abutment.

Procedure: Traditional prosthetic procedure

Arm 3

EXPERIMENTAL

Placing Lance Conical implant together with Connect Abutment (tightened to 30 Ncm) with a Connect healing cap ("one time one abutment"). Screw retained restoration after 3 months.

Procedure: one abutment-one time

Interventions

Traditional prosthetic procedure PROCEDURE

Three months later, after an impression, haling abutment will be removed and a screw-retained restoration will be seated using a Ti-Base abutment.

Arm 1; Arm 2

one abutment-one time PROCEDURE

Three months later, after an impression, a screw-retained restoration will be seated directly on the connect healing

Arm 3

Eligibility Criteria

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

You may not qualify if:

• Any bone augmentation performed on the implant site with a healing period of less than 3 months.
• Local inflammation (including untreated periodontitis).
• Mucosa disease such as erosive lichen planus
• History of local irradiation therapy.
• Presence of osseous lesions
• History of implant failure
• Postextraction sites with less than 6 weeks of healing
• Sever bruxism or cjenching habits
• Persistent intraoral infection.
• Bone type 4.
• Lack of primary stability less than 35 Ncm.
• Need for augmentation procedures during implant surgery.
• Inability to place the implant according to the prosthetic requirements.

Sponsors & Collaborators

• Studio Odontoiatrico Associato Dr. P. Cicchese e L. Canullo: lead
• Alessio Triestino: collaborator

Study Sites (1)

Studi Odontoiatrici Luigi Canullo

Roma, RM, 00199, Italy

RECRUITING

MeSH Terms

Conditions

Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• luigi Canullo, prof

  Studi Odontoiatrici Canullo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luigi Canullo, prof

CONTACT

3476201976; luigi.canullo@gmail.com

Luigi Canullo

CONTACT

luigi.canullo@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 4, 2025
• Study Start: September 1, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 4, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)