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A Randomized Controlled Single-Blind Clinical Study on Immediate Implantation and Immediate Restoration versus Delayed Restoration of a Single Molar Tooth

A Randomized Controlled Single-Blind Clinical Study on Immediate Implantation and Immediate Restoration versus Delayed Restoration of a Single Molar Tooth

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400095012
Enrollment
Unknown
Registered
2024-12-31
Start date
2025-01-01
Completion date
Unknown
Last updated
2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dentition Defect

Interventions

Experimental Group:Immediate restoration after immediate implantation
Control Group:Delayed restoration after immediate implantation

Sponsors

School and Hospital of Stomatology, Cheeloo College of Medicine, Shandong University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Non-Retainable Teeth: Teeth that cannot be preserved, including cases of tooth fractures, teeth with stable periapical diseases, or periodontal diseases that are deemed non-retainable and suitable for immediate implantation treatment. Absence of Acute Lesions Around the Implant Site: No acute pathological conditions in the periodontal or periapical tissues of the affected tooth or adjacent teeth. Ability to Achieve Initial Implant Stability: The morphology of the tooth socket and the remaining bone volume after tooth extraction must ensure sufficient primary stability of the implant post-surgery. Integrity of the Tooth Socket: After tooth extraction, the bony walls of the socket must remain intact, or only favorable bone defects should exist, allowing the implant to achieve initial stability and undergo simultaneous guided bone regeneration (GBR). Healthy and Aesthetically Intact Soft Tissue Around the Implant Site: The soft tissue should be healthy to facilitate healing of the implant site after immediate implantation and support the formation of an aesthetically pleasing and healthy peri-implant soft tissue structure. In cases requiring simultaneous GBR with submerged implant healing, the soft tissue must be intact and healthy to ensure tension-free primary closure of the surgical wound following implant placement.

Exclusion criteria

Exclusion criteria: History of Severe Cardiovascular, Cerebrovascular, or Neurological Disorders: Individuals with a history of severe cardiovascular or cerebrovascular diseases, or neurological disorders such as epilepsy. Uncontrolled Systemic Diseases: Individuals with uncontrolled systemic conditions, such as diabetes or blood disorders. Long-term Use of Bisphosphonates: Patients who have been on long-term bisphosphonate therapy. Heavy Smoking or Alcohol Abuse: Individuals who are heavy smokers (more than 20 cigarettes/day) or habitual alcohol abusers. Limited Mouth Opening Due to Any Disease: Patients with restricted mouth opening caused by any underlying condition. Acute Inflammation in the Affected Tooth or Adjacent Tissues: Presence of acute inflammatory conditions in the tooth or surrounding tissues. Pregnancy and Lactation: Pregnant or breastfeeding women.

Design outcomes

Primary

MeasureTime frame
Peri-implant Bone Remodeling;

Secondary

MeasureTime frame
Implant Success Rate;Jemt Papilla Index;Keratinized Mucosa Width (KMW);Proximal Contact Loss;Emergence Profile;

Countries

China

Contacts

Public ContactYong Wen

School and Hospital of Stomatology, Cheeloo College of Medicine, Shandong University

wenyong@sdu.edu.cn+86 531 8829 2595

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026