Clinical Outcomes of Immediate Implant Placement and Early Implant Placement

Tooth Diseases Clinical Trial

Official title:

Clinical Outcomes of Immediate Implant Placement and Early Implant Placement: a Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04029324
• Other study ID #: 136-2019
• Status: Recruiting
• Phase: N/A
• Start date: July 15, 2019
• Est. completion date: October 1, 2022

Study information

• Verified date: January 2021
• Source: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
• Contact: Junyu Shi, Phd
• Phone: 8653315299
• Email: sakyamuni_jin[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Immediate implant placement (IIP) has been an attractive treatment concept for both patients and clinicians due to reduced surgical interventions and total treatment span. Although soft-tissue alterations or midfacial recession have been demonstrated in previous studies, recent studies have reported positive result following IIP with the modification of surgical interventions. However, high-quality evidence (≥Ib: evidence from at least one randomized controlled trial) on comparing the clinical outcome of IIP with early implant placement (type 2) is limited.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 1, 2022
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age ?18 years
• single hopeless teeth in anterior maxilla
• enough apical bone volume to achieve primary stability (>4mm)

Exclusion Criteria:

• active periodontoal infection
• incomplete buccal bone plate
• unwilling to participate

Related Conditions & MeSH terms

• Tooth Diseases
• Tooth Fractures

Intervention

Procedure:
• tooth extraction
Under local anesthesia, tooth will be extracted atraumatically.
• Implant placement
Dental implants will be placed according to the instructions in fresh sockets or alveolar ridge.
• Bone augmentation
Bone substitute will be used to augment or maintain the bone contour.
• Coronally repositioned flap
After periosteal releasing incision, mucoperiosteal flap will be sutured at a more coronally position

Locations

Country	Name	City	State
China	Shanghai NinthPeoples' Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Midfacial recession	Recession of midfacial gingival level before extraction and 1-year follow-up	1-year follow-up
Secondary	Papillae recession	Recession of papillae before extraction and 1-year follow-up	1-year follow-up
Secondary	marginal bone loss	marginal bone level between crown delivery and 1-year follow-up	1-year follow-up
Secondary	Probing depth	Probing depth between crown delivery and 1-year follow-up	T2:crown delivery, T3: 1-year follow-up
Secondary	Bleeding on probing %	Bleeding on probing % between crown delivery and 1-year follow-up	T2:crown delivery, T3: 1-year follow-up
Secondary	Pink esthetic score		T2:crown delivery, T3: 1-year follow-up
Secondary	Visual Analogue Scale assessement	Visual Analogue Scale on post-operative pain, esthetics and function	T1: immediately after surgery,T2:crown delivery, T3: 1-year follow-up