Success of Implant Restorations After Immediate or Delayed Implant Placement With/Without Ridge Preservation

Dental Implant Clinical Trial

Official title: The Success of Implant Supported Restorations After Immediate Implant Placement or Delayed Implant Placement With or Without Ridge Preservation

Status Not yet recruiting

Clinical Trial Summary

The study aims to compare clinical, radiographic, patient-reported outcomes (PROMs) and cost analysis outcomes in type I, II and socket preserved sites (III/IV) implant placement at 1-year post-loading in all groups.

Clinical Trial Description

This is a prospective, parallel-group, randomized study aiming to compare clinical, radiographic, PROMS and health-economic outcomes of type I, type II and type III/IV (in socket preserved areas) implant placement.

This study included three groups:

i. Immediate implant placement + aputogenous connective tissue graft (CTG) (type I).

ii. Early implant placement (type II, after 6-8 weeks). iii. Delayed/late placement in socket-preserved sites (type III/IV, after 3-6 months).

Up 75-90 adult, systemically healthy patients will be recruited mainly in the new patient and follow-up implant clinics which run every week at the Murcia University Dental Hospital Morales Meseguer. In addition, patients with unrestorable maxillary premolars, canines and incisors will be recruited from other relevant clinics within the same hospital, such as Periodontics, Endodontics/Dental Trauma Restorative Dentistry, Oral Surgery and Hypodontia outpatient clinics. Flyers advertising the study will also be placed in the Hospital and in the reception area to be visible.

After screening patients, the potentially eligible participants will be given the patient information sheet and they will be invited to attend the enrolment visit at Murcia University Dental Hospital Morales Meseguer . Before any study-related intervention is performed, informed consent will be obtained. During the enrolment visit, a detailed medical history will be taken and the periodontal parameters adjacent to the tooth to replace will be recorded. The GDP will be sent a letter to inform him/her about the enrolment of their patient in the study and about the need for any dental treatment (if needed).

Below is a summary of all study visits for each study group:

1. For type-I placement:

Visit 1: Screening and oral hygiene improvement, non-invasive imaging baseline (intraoral scanning, pre-extraction CBCT) and impressions for temporary replacement.

Visit 2: Extraction, CBCT post extraction and provision of immediate implant. Visit 3:

Suture removal. Visit 4: Provision of second stage surgery after 12-14 weeks. Visit 5:

Impressions for temporary restoration after 2 weeks. Visit 6: Provision of temporary restoration after 2-4 weeks. Visit 7: Impressions for final restoration after 3-6 months. Visit 8: Provision of final implant restoration. Visit 9: Final visit for data collection at 12 months post-loading and CBCT.

2. For type-II placement:

Visit 1: Screening and oral hygiene improvement, non-invasive imaging baseline (intraoral scanning, pre-extraction CBCT) and impressions for temporary replacement.

Visit 2: Extraction, CBCT post extraction. Visit 3: Suture removal after 1-2 weeks. Visit 4: Provision of type II placement after 6-8 weeks. Visit 5: Suture removal after 1-2 weeks. Visit 6: Provision of second stage surgery after 12-14 weeks. Visit 7: Impressions for temporary restoration after 2 weeks. Visit 8: Provision of temporary restoration after 2-4 weeks. Visit 9: Impressions for final restoration after 3-6 months. Visit 10: Provision of permanent implant restoration. Visit 11: Final visit for data collection at 12 months post-loading and CBCT.

3. For socket-preserved sites with type-III/IV placement:

Visit 1: Screening and oral hygiene improvement, non-invasive imaging baseline (intraoral scanning, pre-extraction CBCT) and impressions for temporary replacement.

Visit 2: Extraction, CBCT post extraction and provision of ARP. Visit 3: Suture removal after 1-2 weeks. Visit 4: Visit 5: Provision of type III/IV placement after 12-24weeks. Visit 5: Suture removal after 1-2 weeks. Visit 6: Provision of second stage surgery after 12-14 weeks. Visit 7: Impressions for temporary restoration after 2 weeks. Visit 8: Provision of temporary restoration after 2-4 weeks. Visit 9: Impressions for final restoration after 3-6 months. Visit 10: Provision of final implant restoration. Visit 11: Final visit for data collection at 12 months post-loading and CBCT. ;

Related Conditions & MeSH terms

• Dental Implant

• NCT number: NCT05988281
• Study type: Interventional
• Source: Hospital General Universitario Morales Meseguer
• Contact: Ruben Garcia-Sanchez, Dr.
• Phone: (+44)7864929396
• Email: ruben.garciasanchez@gstt.nhs.uk
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2023
• Completion date: December 2029