Comparing the esthetic results and efficiency of 2 treatment protocols: the conventional approach using provisional crowns to sculpt the soft tissue before fabrication of the final crown, and a faster protocol, in which the final crown is finished directly without provisional crown phase.

Clinical, esthetic outcomes and efficiency of the one crown one time concept compared to the conventional approach encompassing soft tissue conditioning for the fabrication of single implant crowns: a pilot randomized controlled multicenter clinical trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN98697476

Enrollment

Registered

2017-11-21

Start date

2017-11-30

Completion date

Unknown

Last updated

2017-12-18

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

Conditions

Missing single tooth Oral Health Missing single tooth

Interventions

Participants with a single missing tooth and an implant already placed in the anterior region are randomly allocated to one of two groups: Control group: Participants receive a provisional implant c

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Older 22 years old 2. Patients with Conelog Implants placed in the anterior and premolar region in the maxilla or mandible. 3. These implants should: 3.1. Allow for a screw retained reconstruction 3.2. Be submerged (second stage surgery is the 1st study appointment) 4. Two neighboring teeth are present, or one tooth and one implant 5. Capable of providing written informed consent 6. Obtained informed consent from the patient 7. 2mm band of keratinized mucosa at implant site 8. Patients with adequate oral hygiene Plaque Index < 20% or persistent intraoral infection BoP < 20%

Exclusion criteria

Exclusion criteria: 1. Medical condition that contraindicates surgery: ASA -score = III 2. History of radiotherapy in the head and neck region 3. History of bisphosphonate medication 4. Women of childbearing potential with a positive urine pregnancy test 5. Medium smokers = 10 cigarettes per day 6. Patients unwilling or incapable of understanding and signing the informed consent 7. Pronounced esthetic expectations 8. Severe bruxism or clenching habits

Design outcomes

Primary

Measure	Time frame
1. Esthetic outcome is measured using the "PES/WES”: which is an esthetic index described by Belser in 2009 which is done by taking photographs (the photographs are examined and given points to different parameter, such as papilla fill, texture of soft tissue, volume, or color of soft tissue) at each follow up appointment 2. Volumetric changes is measured using digital models of the site of interest through the intraoral impression system	—

Measure

Time frame

1. Esthetic outcome is measured using the "PES/WES”: which is an esthetic index described by Belser in 2009 which is done by taking photographs (the photographs are examined and given points to different parameter, such as papilla fill, texture of soft tissue, volume, or color of soft tissue) at each follow up appointment 2. Volumetric changes is measured using digital models of the site of interest through the intraoral impression system

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Secondary

Measure	Time frame
1. Biologic soft tissue outcomes is measured by registering the PPD (periodontal pocket depth), bleeding, and plaque around the implant crown at the follow up visit, which we would do anyway in routine control visits after crown placement 2. Biologic hard tissue outcomes is measured by registering the bone level changes: a small periapical radiograph is taken to evaluate bone level changes around the implant crown at the follow up visit 3. Efficiency comparison of the 2 protocols measured registering the time it takes in each procedure, and adding the time for all the procedures in the same protocol group. After, once the esthetic outcomes have been summed up, we may discus if the higher efforts of the control group was worth it.	—

Measure

Time frame

1. Biologic soft tissue outcomes is measured by registering the PPD (periodontal pocket depth), bleeding, and plaque around the implant crown at the follow up visit, which we would do anyway in routine control visits after crown placement 2. Biologic hard tissue outcomes is measured by registering the bone level changes: a small periapical radiograph is taken to evaluate bone level changes around the implant crown at the follow up visit 3. Efficiency comparison of the 2 protocols measured registering the time it takes in each procedure, and adding the time for all the procedures in the same protocol group. After, once the esthetic outcomes have been summed up, we may discus if the higher efforts of the control group was worth it.

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Countries

Germany, Switzerland

Contacts

Public ContactCristina Zarauz

Outcome results

None listed

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