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A randomized controlled trial of the effect of soft and hard tissue argumentation on preventing peri-implant diseases and maintaining contour aesthetics.

A randomized controlled trial of the effect of soft and hard tissue argumentation on preventing peri-implant diseases and maintaining contour aesthetics.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000032828
Enrollment
Unknown
Registered
2020-05-12
Start date
2020-05-01
Completion date
Unknown
Last updated
2020-05-18

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

Conditions

peri-implant diseases and defect of contour aesthetics

Interventions

Group 2:bone argumentation with absorbable biomembrane and bone substitute
Group 1:soft tissue argumentation with subepthelia connective soft tissue graft

Sponsors

Shanghai Ninth People's Hospital, Shanghai Jiaotong University, School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1) Male or female patients aged 18 to 65 years; 2) Single or mutiple teeth lost needed implant restoration, the loss of anterior teeth at least 1 month, and the loss of posterior teeth at least 3 months; 3) Buccal contour defect of single edentulous site (natural teeth or natural teeth with restorations near the single edentulous site) in a prosthetic-guided position, but the residual alveolar bone is available to maintain the initial stability of implant, and ensure no implant exposure (the single edetulous site with GBR included); 4) Adequate residual alveolar bone height to palce a implant with length >= 8mm; 5) Participants signed informed consent before the implementation of any study.

Exclusion criteria

Exclusion criteria: 1) Localized inflammation of adjacent teeth (uncontrolled periodontitis included); 2) Untreated acute and chronic periapical periodontitis of adjacent teeth; 3) Oral mucosal lesions (such as lichen planus); 4) Occupying lesions of adjacent teeth (including cyst, tumor, etc.); 5) Systemic disease that affecting bone healingwound healing and dental implant placement (including uncontrolled diabetes, fasting glucose >= 8.8mmol/l); 6) Uncontrolled and severe hypertension; 7) Contraindications of irregular implant placement and oral surgery(bone grafting included); 8) Heart disease (grade II and above); 9) Liver and kidney dysfunction or abnormality; 10) History of whole dose radiotherapy and local radiotherapy of the head and neck 11) Long-term high-dose steroids therapy; 12) Treatment with drugs that may affect or promote bone metabolism in the past 3 months; 13) Alcohol or drug abuse; 14) Immunologic inadequacy ; 15) Smoking habit of more than 10 cigarettes per day; 16) Neurological or psychiatric handicap that could interfere with good oral hygiene.

Design outcomes

Primary

MeasureTime frame
Peri-implant health indicators such as probing depth and bleeding;

Secondary

MeasureTime frame
Buccal contour profile;

Countries

China

Contacts

Public ContactLi Chaolun

Ninth People's Hospital, Shanghai Jiaotong University, School of Medicine

13701822375@126.com+86 18019790307

Outcome results

None listed

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