Impact of placement and restoration timing on single-implant esthetic outcome - a randomized clinical trial.
Dominik Rieder, Jochen Eggert, Tim Krafft...
https://pubmed.ncbi.nlm.nih.gov/25496243Actively Recruiting
Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID02814149
Esthetic, Clinical and Radiographic Outcomes of Immediate and Delayed Implant Placement in the Anterior Region of the Maxilla
Led by Sun Yat-sen University · Updated on 2019-11-01
40
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to compare esthetic, clinical, and patient-centered outcomes following two dental implant placement protocols in patients missing a single tooth in the upper front jaw area. The study evaluates how gums and bone heal and change shape after tooth extraction using immediate versus delayed implant placement methods. The goal is to better understand tissue healing and bone volume changes over time with these two approaches. Participants are placed into two groups: one receiving an implant immediately after tooth extraction in a single procedure, and the other receiving an implant after the site has healed for three months. Both groups are monitored with procedures involving dental implants placed in the anterior maxillary region. This observational period lasts up to 10 years after the initial treatment to assess long-term outcomes. During the study, participants will have various assessments including esthetic scoring of gum and tooth appearance, radiographic bone volume measurements, and clinical evaluations such as implant survival, plaque and bleeding indices, probing depths, gum recession, papilla size, keratinized tissue width, and patient-reported outcome measures like pain and oral health impact. Follow-up visits and evaluations occur over a 10-year period to track healing and implant success.
CONDITIONS
Brief Title
Esthetic, Clinical and Radiographic Outcomes of Immediate and Delayed Implant Placement
Who Can Participate
Age: 18Years - 80Years
All Genders
Eligibility Criteria
You may qualify if you...
- At least 18 years old and able to understand an informed consent
- Adequate oral hygiene to allow for implant therapy consistent with standards of care
- Missing a single tooth in the maxillary anterior region
- Presence of adjacent natural teeth
You will not qualify if you...
- Poor oral hygiene
- Severe parafunctional habits, for example, bruxing and clenching
- Presence of clinically active periodontal disease with probing pocket depths 6 mm and bleeding on probing
- Conditions that may reduce bone healing capacity, such as osteoporosis and Paget's disease
- Pregnant or expecting to be pregnant
- History of drug and alcohol abuse
- Systemic diseases contraindicating oral surgery, such as uncontrolled diabetes with HBA1c >7%
- Radiotherapy in the head and neck area
- Current or recent use (within 3 months) of bisphosphonates or steroids
- Absence of adjacent teeth
- Unwillingness to return for follow-up exams
- Smoking more than 20 cigarettes per day; those smoking less than 20 must stop before and after surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - Immediate implant placement on day of tooth extraction or delayed implant placement after 3 months healing
Participants undergo either immediate implant placement following tooth extraction or delayed implant placement after a healing period of 3 months.
1 surgical procedure visit and immediate post-operative care visits
Post-operative Follow-up
Duration - Up to 10 years after baseline
Participants are followed to monitor soft tissue and bone healing around dental implants, including esthetic and radiographic assessments.
Regular follow-up visits over 10 years
Trial Site Locations
Total: 1 location
1
Guanghua School of Stomatology Hospital of Stomatology
Guangzhou, Guangdong, China, 510000
Actively Recruiting
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Research Team
X
Xin Liu
B
Baoxin Huang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Esthetic, clinical and patient-centered outcomes of immediately placed implants (Type 1) and early placed implants (Type 2): preliminary 3-month results of an ongoing randomized controlled clinical trial.
Guy Huynh-Ba, David J Meister, Ashley B Hoders...
https://pubmed.ncbi.nlm.nih.gov/25758100