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A MULTICENTER RANDOMIZED CONTROLLED STUDY COMPARING EARLY IMPLANT PLACEMENT TO ALVEOLAR RIDGE PRESERVATION FOR SINGLE TOOTH REPLACEMENT IN THE ANTERIOR AREA

Organizational Data

DRKS-ID:
DRKS00018875
Recruitment Status:
Recruiting complete, study continuing
Date of registration in DRKS:
2020-01-03
Last update in DRKS:
2023-02-13
Registration type:
Prospective

Acronym/abbreviation of the study

RP vs EP

URL of the study

No Entry

Brief summary in lay language

After tooth extraction, the socket can show bone loss around and therefore should be treated in order to minimize this loss. Basically there are two kinds of treatment. One consists of filling the socket with biomaterial and placing the implant some months later; the other one consists of placing the implant in the socket together with the biomaterial. The biomaterial should preserve the socket from loosing the bone during the healing process after tooth extraction. The principal aim of the present study is to compare the two treatment modalities and see if both contribute to keep the implant in place for long time. The hypothesis is that the filling of the socket with biomaterial gives better results than the other treatment.

Brief summary in scientific language

Both soft and hard tissue contribute to the overall peri-implant volume and health. The preservation and augmentation of these two factors have been analyzed separately but little attention has been paid to the end results combining both factors. After tooth extraction, sockets in the aesthetic region can be treated in different ways which affect the overall volume. Two of the most utilized treatment protocols are ridge preservation with delayed implant placement and early implant placement with simultaneous guided bone regeneration. These two treatment modalities have never been compared in terms of overall volume changes, aesthetic results and patient- reported outcome measures. The principal aim of the present study is to assess contour changes on the buccal side of the extraction site from pre-tooth extraction up to 5 months applying two protocols for implant placement.The hypothesis is that ridge preservation procedure is better than early implant placement procedure in terms of contour changes from pre-tooth extraction to 5 months later.

Health condition or problem studied

ICD10:
K00-K14 - Diseases of oral cavity, salivary glands and jaws
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 1:
Ridge preservation (placement of the implant 5 months after tooth extraction and filling with biomaterials)
Arm 2:
Early Implant Placement (Placement of the implant 2 months after tooth extraction and together with biomaterials)

Endpoints

Primary outcome:
The primary outcome will be contour changes (mm) at the buccal aspect of the extraction site from pre-tooth extraction (baseline) to 5 months later by volumetric analysis.
Secondary outcome:
• profilometric outcomes (horizontal changes) at screening, T0, T1, T2, T3, T4, T5, T6. • clinical parameters (probing depth, bleeding on probing, plaque index, keratinized mucosa) at screening, T3, T4, T5, T6 by using a dental probe • aesthetic (PES, WES) at screening, T3, T4, T5, T6 by dentist's score • marginal bone level and buccal bone thickness at T0, T2, T3, T6 by radiographic methods •i mplant survival at T3, T4, T5, T6 by observing whether the implant is in place or not • patient-reported outcome measures at T0, T1, T2, T3, T4, T5, T6 by questionnaires • costs at T3, T4, T5 and T6. • need for additional Guided Bone Regeneration at T1, T2. • need for an additional soft tissue grafting procedure at T2. • Dentist's VAS score for ease of treatment for the dentist at T0, T1, T2. • Dentist's VAS for Treatment Satisfaction for the dentist at T3,T4,T5,T6 • Technical parameters at T3, T4,T5,T6 by using USPHS criteria

Study Design

Purpose:
Prevention
Allocation:
Randomized controlled study
Control:
  • Active control (effective treatment of control group)
Phase:
IV
Study type:
Interventional
Mechanism of allocation concealment:
No Entry
Blinding:
No
Assignment:
Parallel
Sequence generation:
No Entry
Who is blinded:
No Entry

Recruitment

Recruitment Status:
Recruiting complete, study continuing
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Belgium
  • Switzerland
Number of study centers:
Multicenter study
Recruitment location(s):
  • University medical center Zürich

Recruitment period and number of participants

Planned study start date:
2020-01-31
Actual study start date:
2020-02-11
Planned study completion date:
No Entry
Actual Study Completion Date:
No Entry
Target Sample Size:
46
Final Sample Size:
47

Inclusion Criteria

Sex:
All
Minimum Age:
20 Years
Maximum Age:
no maximum age
Additional Inclusion Criteria:
1. Periodontally healthy individuals with at least 20 years of age 2. Good oral hygiene (BOP & PlI ≤ 20%) 3. Patients with a failing single tooth in the maxilla and mandible, from second premolar to second premolar 4. At least 50% of the buccal bone plate intact after tooth extraction 5. At least one neighboring natural tooth 6. Presence of antagonist 7. Capability to comply with the study procedures 8. Informed Consent as documented by signature

Exclusion Criteria

1. Pregnant or lactating women 2. Known or suspected non-compliance, drug or alcohol abuse 3. Smokers (>10 cigarettes/day) 4. Systemic or local conditions presenting a contraindication to implant treatment 5. Currently taking drugs that influence bone metabolism 6 .Use of bisphosphonates in the last 4 years 7. History of malignancy, radiotherapy or chemotherapy for malignancy in the past 5 years

Addresses

Primary Sponsor

Clinic of Reconstructive DentistryCenter of Dental MedicineUniversity Zurich
PD Dr.med.dent. Daniel Thoma
Plattenstrasse 11
8032 Zürich
Switzerland
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Clinic of Reconstructive DentistryCenter of Dental MedicineUniversity Zurich
PD Dr.med.dent. Daniel Thoma
Plattenstrasse 11
8032 Zürich
Switzerland
Telephone:
0041 44 634 04 04
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Contact for Public Queries

Clinic of Reconstructive DentistryCenter of Dental MedicineUniversity Zurich
PD Dr.med.dent. Daniel Thoma
Plattenstrasse 11
8032 Zürich
Switzerland
Telephone:
0041 44 634 04 04
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Principal Investigator

Clinic of Reconstructive DentistryCenter of Dental MedicineUniversity Zurich
PD Dr.med.dent. Daniel Thoma
Plattenstrasse 11
8032 Zürich
Switzerland
Telephone:
0041 44 634 04 04
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Sources of Monetary or Material Support

Private sponsorship (foundations, study societies, etc.)

ITIFoundation
Peter Merian Strasse 88
4052 Basel
Switzerland
Telephone:
0041 61 270 83 79
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Ethics Committee

Address Ethics Committee

Kantonale Ethikkommission Zürich
Stampfenbachstrasse 121
8090 Zürich
Switzerland
Telephone:
(+41)43-2597970
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2019-10-18
Ethics committee number:
2019-01984
Vote of the Ethics Committee:
Approved
Date of the vote:
2019-11-21

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No
IPD Sharing Plan:
Study Synopsis

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
No Entry
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry