Apico-coronal Position of Tissue-level Implants Bone Stability

NCT05363306 | Completed

• 1 other identifier: TLMBS
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

early marginal bone loss around dental implants may hamper long term prognosis of implant-prosthetic rehabilitation. this study aimed to study the correlation of pico-coronal position of dental implant (from supracrestal, crystal to undergone level) measuring early marginal bone loss through periapical x-ray at surgical time and subsequent follow-ups.

Conditions

Bone Atrophy, Alveolar

Keywords

osseointegrated implant; early marginal bone loss;

Outcome Measures

Primary Outcomes (1)

• early marginal bone loss

  distance from crystal bone to most coronal bone to implant contact

  5 months after implant placement

Secondary Outcomes (1)

• biological complications

  during surgery

Study Arms (3)

thin crestal mucosa

Based upon vertical mucosa thickness measured at implant placement, implants were placed: 2mm below the crestal bone in presence of thin mucosa (\< 2.5mm)

Procedure: implant insertion

medium crestal mucosa

Based upon vertical mucosa thickness measured at implant placement, implants were placed: 2) 1mm below the crestal bone in presence of medium mucosa (2.5-3.5mm);

Procedure: implant insertion

thick crestal mucosa

Based upon vertical mucosa thickness measured at implant placement, implants were placed: 1) at crestal level in presence of thick mucosa (\> 3.5 mm);

Procedure: implant insertion

Interventions

implant insertion PROCEDURE

4% articaine solution, a mid-crestal incision along the center of the edentulous bone ridge was performed. A full-thickness flap was elevated. The sites were prepared to permit insertion of transmucosal, external hex, implants (I-smart, I-RES, Lugano, Switzerland) at three different crestal levels, based upon vertical mucosa thickness measured at implant placement. Owing to width crest, all implants were 3.75 mm in diameter and operators selected appropriate implant lengths (8, 10 mm) according to available bone crest height. All implants were not submerged and flaps were sutured around the transmucosal component.

medium crestal mucosa; thick crestal mucosa; thin crestal mucosa

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients were partially edentulous and required placement of at least one single delayed implant in pristine bone in the posterior mandible

You may qualify if:

• Patients were partially edentulous and required placement of at least one single delayed implant in pristine bone in the posterior mandible
• presence of keratinized mucosa with a minimum bucco-lingual width of 3 mm;
• bone crest with at least 6mm of width and 9 mm of height above the mandibular canal without concomitant or previous bone augmentation procedures;
• presence of the opposing dentition

You may not qualify if:

• smokers
• uncontrolled periodontitis
• medication consumption for at least 3 months prior to treatment
• history of head or neck radiation therapy
• pregnancy or lactating at any time during the study

Sponsors & Collaborators

• International Piezosurgery Academy: lead

Study Sites (2)

Hesire

Cassano Allo Ionio, CS, 87011, Italy

Location

Piezosurgery Academy

Parma, 43100, Italy

Location

Related Publications (2)

• Lombardi T, Berton F, Salgarello S, Barbalonga E, Rapani A, Piovesana F, Gregorio C, Barbati G, Di Lenarda R, Stacchi C. Factors Influencing Early Marginal Bone Loss around Dental Implants Positioned Subcrestally: A Multicenter Prospective Clinical Study. J Clin Med. 2019 Aug 4;8(8):1168. doi: 10.3390/jcm8081168.

  PMID: 31382675 BACKGROUND

• Spinato S, Bernardello F, Stacchi C, Soardi CM, Messina M, Rapani A, Lombardi T. Marginal Bone Changes Around Tissue-Level Implants After Prosthesis Delivery: A Multicenter Prospective Study. Clin Implant Dent Relat Res. 2025 Jun;27(3):e70071. doi: 10.1111/cid.70071.

  PMID: 40500982 DERIVED

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Teresa Lombardi, Dr.

  Hesire dental office

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2022
• First Posted: May 5, 2022
• Study Start: January 1, 2021
• Primary Completion: July 1, 2021
• Study Completion: March 1, 2022
• Last Updated: May 5, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)