Narrow Implants Vs Standard Implants With Simultaneous GBR

Not Applicable

Recruiting

• Conditions: Bone Regeneration; Dental Implant; Narrow Implant
• Interventions: Procedure: Test group; Procedure: Control group

• Registration Number: NCT06168500
• Lead Sponsor: Universitat Internacional de Catalunya

Brief Summary

NDI represent an advisable treatment option when the mesio-distal space is compromised. In a recent retrospective study with a follow-up of 8 years in which they wanted to evaluate the long-term survival, complications, peri-implant conditions, marginal bone loss, and patient satisfaction of fixed dental prostheses supported by NDI in the posterior area. They observe a survival rate of 97% and absence of prosthetic complications after the study period time. More recently, Souza et al. performed a prospective randomized split mouth study with 3 years follow-up with the aim of comparing marginal bone level, implant survival and success rates and prosthesis success rates of NDI and SDI placed in the posterior area of the mandible to support single prosthesis. They observed an implant survival rate of 100% for both groups at 1 and 3 years. The prosthesis success rate at 1 and 3 years was of 95.4% and 100%, respectively.

NDI present a high survival rate on the evaluated studies. Therefore, the aim of the first study is to compare the patient related outcomes, implants and prostheses success and survival rates of pure titanium NDI versus SDI with simultaneous bone regeneration in narrow alveolar ridges at posterior areas of the maxilla and the mandible.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-12
• Study First Submitted: 2023-11-15
• Study First Submitted QC: 2023-12-04
• Study First Posted: 2023-12-13
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-28
• Last Update Posted: 2024-05-29
• Primary Completion: 2024-12-28
• Study Completion: 2025-12-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

Patients:

• 18 years old
• Healthy periodontal status (absence of generalized probing pocket depth (PPD) <4mm)
• Oral hygiene levels (FMPS <20 and FMBS <20)

Site:

• Ridge width of >5mm and <6.5mm and minimum bone height of 10mm prior evaluation on a CBCT scan
• Presence of antagonistic natural tooth or fixed prosthetic restoration
• Presence of adjacent teeth
• One maxillary or mandibular premolars
• Minimum of 3mm of keratinized tissue over the bone crest (20)
• Bone regeneration within the limits of the prosthetic restoration.

Implants:

• Unitary prosthesis
• Screwed retained restorations

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Exclusion Criteria

Patients

• Presence of active chronic or aggressive periodontal disease
• Presence of systemic disease which contraindicate surgery (patients with an ASA ≥ 3)
• Drugs or medications which may alter the results (chronic intake of analgesic medication)
• Smokers (>10cig/day)
• Pregnant women
• History of head and neck radiotherapy.

Site

• Anterior area (from 1.3 to 2.3 and from 3.3 to 4.3) and molar area
• Previous guided bone regeneration
• Location where there is not sufficient restorative space (mesio-distally <8mm for every restoration unit and <5mm from the bone crest to the antagonist)
• Implant dehiscence of more than 2/3 of the implant.

Implant

• Implants which cannot be restored with a screwed restoration
• Implants which doesn't reach a manual implant stability
• implants which after placement doesn't reach a favourable position according to the restoration.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Control group	-
Test Group	Control group	-
Control group	Test group	-
Test Group	Test group	-

Primary Outcome Measures

Name	Time	Method
Marginal bone level difference	The changes in MBL will be registered at 8 weeks, 6 months, 12 months, and 3 years.	To assess the MBL, each radiograph must register the most coronal aspect of the bone crest (BC) at mesial and distal to the implant, the position of the implant shoulder (IS) and the first bone to implant contact (FBiC). The marginal bone crest level (MBL) will be measured by calculating the distance between BC and IS. MBL will be considered negative when position of BC is coronal to IS, positive when position BC is apical to IS.

Secondary Outcome Measures

Name	Time	Method
Patient related outcomes	At 1, 2 and 12 weeks	- Level of discomfort - at 1-, 2- and 12-weeks post-surgery (VAS scale): 0 - 4 (being 0 no discomfort and 4 very severe discomfort)
Resonance frequency analysis	Implant surgery and after 12 months	Resonance frequency analysis using Penguin ® will be measured immediately after implant placement, when taking implant impressions
Peri-implant mucosal thickness using a millimetre probe	12 months
Prosthesis success criteria	12 months	* Absence of prosthesis (crown or abutment) mobility; * Number of maintenance visits; * Crown screw loosening; * Abutment screw loosening; * Implant fracture; * Crown screw fracture; * Abutment screw fracture; * Crown chipping.
Implant success criteria:	12 months	Defined as absence of: * Persistent pain, foreign body sensation, and/or dysesthesia; * Recurrent peri-implant infection with suppuration; * Implant mobility; * Continuous radiolucency around the implant; * Clinical probing depth (CPD) ≥5 mm associated with bleeding/suppuration on probing (BoP/SoP).
Presence of peri-implant health	At 12 weeks, 6 and 12 months	Defined as: * Peri-implant probing depth (6 points).; * Bleeding on probing (presence or absence).; * Suppuration on probing (presence or absence).; * Plaque index (presence or absence).
Presence of post-surgical complications	At 1, 2 and 12 weeks	Defined as absence of: * Infection/suppuration; * Wound dehiscence; * Implant failure; * Post-op oedema
Presence of prosthetic complications	At 6 and 12 months	Defined as: * Number of maintenance visits; * Crown screw loosening ("Yes" or "No"); * Abutment screw loosening ("Yes" or "No"); * Implant fracture ("Yes" or "No"); * Crown screw fracture ("Yes" or "No"); * Abutment screw fracture ("Yes" or "No"); * Framework fracture ("Yes" or "No"); * Crown ceramic chipping ("Yes" or "No")
Patient Related Outcomes	At 7 days	Medication required: Number of ibuprofen tablets taken between the 2nd and the 7th day.
Implant survival criteria:	12 months	Defined as the implant being still in function
Level of keratinized tissue surrounding the implants	12 months	Level of keratinized tissue will be measured from the gingival margin of the restored implant to the mucogingival line using a periodontal millimetre probe.

Trial Locations

Locations (1)

Universitat Internacional de Catalunya; 🇪🇸 Sant Cugat Del Vallès, Barcelona, Spain