Narrow Implants Vs Standard Implants With Simultaneous GBR

Dental Implant Clinical Trial

Official title:

Narrow Diameter Implants Versus Standard Diameter Implants With Simultaneous Bone Regeneration For The Treatment Of Atrophic Posterior Area

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06168500
• Other study ID #: PER-ECL-2018-06
• Status: Recruiting
• Phase: N/A
• Start date: July 12, 2021
• Est. completion date: December 28, 2024

Study information

• Verified date: December 2023
• Source: Universitat Internacional de Catalunya
• Contact: Rodrigo González Terrats, Dentistry
• Phone: 0034618265213
• Email: rodrigt_11[@]uic.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 26
• Est. completion date: December 28, 2024
• Est. primary completion date: December 28, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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 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.

Related Conditions & MeSH terms

• Bone Regeneration
• Dental Implant
• Narrow Implant

Intervention

Procedure:
• Test group
3.0mm diameter implant
• Control group
4.0 diameter implant + guided bone regeneration

Locations

Country	Name	City	State
Spain	Universitat Internacional de Catalunya	Sant Cugat Del Vallès	Barcelona

Sponsors (3)

Lead Sponsor	Collaborator
Universitat Internacional de Catalunya	Botiss Medical AG, Klockner Implant System S.A.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Marginal bone level difference	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.	The changes in MBL will be registered at 8 weeks, 6 months, 12 months, and 3 years.
Secondary	Patient related outcomes	- Level of discomfort - at 1-, 2- and 12-weeks post-surgery (VAS scale): 0 - 4 (being 0 no discomfort and 4 very severe discomfort)	At 1, 2 and 12 weeks
Secondary	Patient Related Outcomes	Willingness of undergoing same surgical procedure - at 1-, 2- and 12-weeks post-surgery (VAS scale): 0 - 4 (being 0 will never undergo this surgery again and 4 no problem to repeat this surgery)	At 1, 2 and 12 weeks
Secondary	Patient Related Outcomes	- Level of pain perceived - during first 7 days after surgery (VAS scale): 0-100 (being 0 no pain and 100 intolerable pain)	At 7 days
Secondary	Patient Related Outcomes	Medication required: Number of ibuprofen tablets taken between the 2nd and the 7th day.	At 7 days
Secondary	Implant survival criteria:	Defined as the implant being still in function	12 months
Secondary	Implant success criteria:	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).	12 months
Secondary	Prosthesis success criteria	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.	12 months
Secondary	Resonance frequency analysis	Resonance frequency analysis using Penguin ® will be measured immediately after implant placement, when taking implant impressions	Implant surgery and after 12 months
Secondary	Level of keratinized tissue surrounding the implants	Level of keratinized tissue will be measured from the gingival margin of the restored implant to the mucogingival line using a periodontal millimetre probe.	12 months
Secondary	Peri-implant mucosal thickness using a millimetre probe		12 months
Secondary	Presence of post-surgical complications	Defined as absence of: Infection/suppuration; Wound dehiscence; Implant failure; Post-op oedema	At 1, 2 and 12 weeks
Secondary	Presence of peri-implant health	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).	At 12 weeks, 6 and 12 months
Secondary	Presence of prosthetic complications	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")	At 6 and 12 months