Condition category
Oral Health
Date applied
22/07/2020
Date assigned
23/07/2020
Last edited
23/07/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The introduction of dental implants as an option to replace missing teeth was considered one of the most revolutionary developments in modern dentistry. However, one of the main drawbacks with the first dental implants was the time required for the treatment to be completed. One of the stages that delayed the overall treatment considerably was the waiting time for the gum and the bone to heal once a tooth had been extracted (3-6 months) before a dental implant could be placed. Quite recently, a new approach was described in which a dental implant was placed immediately in the socket left after a tooth was removed. This proved to be a very valid modality of treatment that reduced considerably the time needed to place an implant. As surgical techniques evolved, it was noticed that the less trauma caused during the immediate implant placement, the better the healing was. This led to the consideration of placing immediate dental implants without lifting the gums due to the potential advantages this may have for the healing of the gum and the bone afterwards. At the present, there are not many studies looking into this surgical aspect of immediate dental implants, so the aim of this study is to compare the gum and bone healing in immediate dental implants placed with and without gum lifting/flap.

Who can participate?
Patients aged over 18 requiring single tooth extraction in the upper anterior and premolar region of the mouth

What does the study involve?
Participants are randomly allocated to receive immediate dental implants placed with and without gum lifting/flap. Both groups will receive hard and soft tissue grafting as part of the procedure. Dental implant survival and success are measured after 1 year.

What are the possible risks and benefits of participating?
The main benefit of this study is providing the participants with a dental implant to replace a missing tooth instead of another treatment modality that would not suit their needs or may have a negative impact in neighbouring teeth, such as fixed dental prosthesis. The potential risks associated with this treatment modality are mainly associated with the minor surgical procedure needed to place a dental implant and the unlikely scenario in which a dental implant failed. The main items are listed below:
Swelling of the lips, chin, cheeks, and other tissues of the face, mouth, and neck with possible bruising and discoloration. Damage to and possible loss of other teeth, fillings, or other dental work, which will require root canal treatment, tooth extraction, or new fillings or restorations. Infection which will require antibiotic treatment, possibly further surgery, and may lead to loss of the implant. Discomfort which may require the use of pain medication for several days or longer, and which will also require at-home recuperation for the same period of time or longer. Bleeding which may be prolonged or heavy, and may require additional surgery or other treatment. Sinus or nasal problems, including but not limited to nasal stuffiness, bleeding, infection, or creation of an opening between the nose or sinus and mouth, which may require surgery. Poor healing of the gum tissue which may result in exposure of the implant and its loss. Loss or resorption of the bone which may result in failure of the implant. Injury of the nerves near the treatment site which cause pain, numbness, or tingling of the lips or areas of the face. This effect is usually temporary but may be permanent. Stretching or damage to the corners of the mouth with cracking, bleeding, and bruising.

Where is the study run from?
Universidad de Murcia (Spain)

When is the study starting and how long is it expected to run for?
October 2016 to May 2020

Who is funding the study?
1. Universidad de Murcia (Spain)
2. Avivent (Spain)
3. Osteogenoss (Spain)

Who are the main contacts?
1. Dr Ruben Garcia
ruben.garciasanchez@gstt.nhs.uk
2. Dr Guillermo Pardo Zamora
gparza@um.es

Trial website

Contact information

Type

Scientific

Primary contact

Dr Ruben Garcia Sanchez

ORCID ID

http://orcid.org/0000-0003-2051-0668

Contact details

Periodontology Unit
Floor 25
Guy's Hospital
Great Maze Pond
London
SE1 9RT
United Kingdom
+44 (0)7864929396
ruben.garciasanchez@gstt.nhs.uk

Type

Scientific

Additional contact

Dr Guillermo Pardo Zamora

ORCID ID

Contact details

Facultad de Odontología - Universidad de Murcia Hospital Morales Meseguer
Avda. Marqués de los Vélez s/n
Murcia
30008
Spain
+34 (0)606064848
gparza@um.es

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

1738/2017

Study information

Scientific title

Evaluation of soft and hard tissue remodelling in post-extraction immediate dental implants placed with a flap and flapless approach in the aesthetic region. Clinical and radiographic prospective evaluation at one year.

Acronym

Study hypothesis

The aim of this study is to test the main null hypothesis that there are no differences in survival/success rate in a group of patients requiring single immediate DI in the anterior maxillary region treated with a flapless vs. flap approach against the alternative hypothesis of a difference. For the secondary outcomes, the study tests the null hypotheses that there are no differences in "Pink aesthetic score (PES)", cortical plate resorption and "patients' reported outcomes (PROMS)" in a group of patients requiring single immediate DI in the anterior maxillary region treated with a flapless vs. flap approach against the alternative hypothesis of a difference.

Ethics approval

Approved 01/03/2018, ethical committee of Murcia University (Comité Ético de Investigación Clínica (CEIC); Calle Santo Cristo, 1, Murcia, Spain, 30001; +34 (0)868883614; comision.etica.investigacion@um.es), ref: 1738/2017

Study design

Single-center randomized controlled parallel-arm blind study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Soft and hard tissue remodelling in post-extraction immediate dental implants

Intervention

Patients requiring single tooth extraction in the anterior and premolar areas were recruited for this study. Self-tapping, screw-shaped Biomimetic OCEAN, Avinent® implants of different lengths and diameters were immediately placed after dental extraction. In the control group, implant placement was performed with the elevation of a mucoperiosteal flap whereas in the test group this was performed flawless. In all study cases, test and control, discrepancies between the extraction socket and the implant surface were filled with a mix of bone replacement graft (Gen-Os, Osteógenos s.r.l.) and autologous bone, covered with a collagen membrane (Evolution, Osteógenos, s.r.l). In addition, soft tissues were augmented by the use of autogenous connective tissue graft.

Randomization was done by balanced block randomization using a computer-generated table with random numbers. Treatment assignment was concealed to the treating surgeon by opaque envelopes that were opened only after completion of tooth extraction and final assessment of the feasibility of immediate implant placement. Clinical/radiographic measures, aesthetic evaluations and statistical analyses were performed blind with respect to treatment assignment.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measure

1. Dental implant survival, defined as percentage of dental implants that presented successful osseointegration, lack of complications and bone loss less than 0.2 mm/year after loading at 1-year post-loading
2. Dental implant success, defined as percentage of implants that survived and the pink aesthetic score was above 7 and the white aesthetic score was above 5 at 1-year post-loading

Secondary outcome measures

1. Aesthetic of gums measured using the pink aesthetic index at 1-year post-loading
2. Aesthetic of false tooth measured using the white aesthetic index at 1-year post-loading
3. Buccal plate resorption measured using cone-beam CT at 1-year post-loading
4. Patients' reported outcomes measured using questionnaire and visual analogue scale at 1-year post-loading

Overall trial start date

01/10/2016

Overall trial end date

22/05/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Healthy individuals above 18 years who underwent immediate implant placement following single tooth extraction and were intended to receive implants
2. Non-smokers
3. Enough quantity of native bone to achieve primary stability
3. Patient has adequate mesiodistal space for implant placement
4. Patient available for follow-up according to protocol for 12 months post-loading to be able to assess the results of the proposed investigation

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30

Total final enrolment

28

Participant exclusion criteria

1. Medically compromised patients
2. Smokers
3. Presence of active periodontal disease
4. Symptomatic apical pathology before extraction

Recruitment start date

20/04/2018

Recruitment end date

29/05/2019

Locations

Countries of recruitment

Spain

Trial participating centre

Universidad de Murcia
Universidad de Murcia Hospital Morales Meseguer Avda. Marqués de los Vélez s/n
Murcia
30008
Spain

Sponsor information

Organisation

Hospital General Universitario Morales Meseguer

Sponsor details

Facultad de Odontología - Universidad de Murcia Hospital Morales Meseguer
Avda. Marqués de los Vélez s/n
Murcia
30008
Spain
+34 (0)868888584
gparza@um.es

Sponsor type

Hospital/treatment centre

Website

http://www.murciasalud.es/seccion.php?idsec=367

Funders

Funder type

University/education

Funder name

Universidad de Murcia

Alternative name(s)

University of Murcia

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Spain

Funder name

Avinent

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Osteógenos s.r.l.

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal. Study protocol, PIS, the results of any statistical analysis, statistical analysis plan are provided upon request and under the conditions stated.

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr. Guillermo Pardo Zamora (gparza@um.es). This data will become available once the study results are published. The data available will be all of the individual participant data collected during the trial, after deidentification. This data will be available 3 months after publication and ending 5 years following article publication. This data will be shared with investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. The data will be shared to achieve the aims in the approved proposal. Proposals should be directed to Dr Guillermo Pardo Zamora (gparza@um.es). To gain access, data requestors will need to sign a data access agreement.

Intention to publish date

01/11/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

23/07/2020: Trial's existence confirmed by ethical committee of Murcia University.