Labial Bone Thickness Change in Immediate Implant Placement In Maxillary Esthetic Zone

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorCairo University

About this trial

The goal of this clinical trial is to assess the effect of distance between the implant and the bone on the resultant bone thickness adjacent to the implant in place of a broken down tooth that happens to be bounded by two natural teeth.

The main questions it aims to answer are:

Does the horizontal implant position (and hence the gap between the implant and the socket wall i.e. jumping gap) affect the resultant labial bone thickness? Will it affect the quality of soft tissue, esthetics and patient satisfaction?

Participants will have an implant placed using a surgical guide with a jumping gap either less than 2 mm or equal or more than 2 mm and will be asked to visit the clinic once every 3 months for checkups, radiographs, and readings.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with a bounded single non-restorable upper tooth in the anterior maxilla (15-25) FDI (El Ebiary et al., 2023b)

Patients with an age range of 21 to 65 years old (Levine et al., 2022)

Patients with good oral hygiene with BoP ≤ 10 % (Chapple et al., 2018)

Compliant patients willing to follow up to one year.

Disqualifiers

The presence of acute/active infection related to the non-restorable tooth (Block et al., 2009) cited in (Soegiantho et al., 2023)

Presence of labial bone defect as fenestration/dehiscence (Crespi et al., 2008) cited in (Soegiantho et al., 2023)

Large cyst or pathological lesion related to the tooth (Tallarico et al., 2016-2017) cited in (Soegiantho et al., 2023); (Morton, Wismeijer, Chen, Hamilton, Wittneben, Casentini, Gonzaga, Lazarin, Martin, Molinero-Mourelle, et al., 2023)

History of radiation to the maxilla (Cannizzaro et al., 2010) cited in (Soegiantho et al., 2023)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Immediate implant placement with jumping gap equal to or more than 2 mm

    Procedure/Surgery

    surgically guided placement of a single immediate post-extraction implant in the upper aesthetic zone with a jumping gap \< 2 mm.

  • Immediate implant placement with jumping gap less than 2 mm

    Procedure/Surgery

    surgically guided placement of a single immediate post-extraction implant in the upper esthetic zone with a jumping gap ≥ 2mm.

Treatment groups

22 Participants
are divided into 2 treatment groups
Group A: Immediate implant placement with jumping gap less than 2 mmExperimental treatment 1 intervention
Group B: Immediate implant placement with jumping gap equal to or more than 2 mmActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Δ Labial bone thickness

It will be measured virtually using CBCT measurements, fusion of the C.B.C.Ts will be done.

Time frame
Assessment at baseline and after 12 months.

Secondary outcomes

1

Jumping gap (accuracy)

A preliminary measurement of the jumping gap will be taken from the CBCT during implant planning and patient allocation either into the control or intervention group. These measurements will be done at the patient preparation phase and immediately post implant placement.

Time frame
Before implant placement and immediately after.
2

Crestal Bone Level

It will be measured using periapical radiographs in parallel technique for standardization comparing different bone levels.

Time frame
Assessment at baseline, 3 months, 6 months, 9 months and 12 months.
3

Pink Esthetic Score

It will be measured in scale with numerical value. The Pink Esthetic Score (PES) as proposed by (Fürhauser et al., 2005) contains seven variables: distal papilla, mesial papilla, soft tissue contour, soft tissue level, deficiency of the alveolar process, and soft-tissue texture and color. Each variable was assessed with a 0-1-2 score, with 0 being the worst and 2 being the best.

Time frame
Assessment after final crown delivery (baseline), 3 months, 6 months, 9 months and 12 months.
4

Patient satisfaction

It will be measured using a questionnaire at the end of the study. The questionnaire will be in a form of three questions: 1. Considering this was an elective operation, how likely would you be to recommend it to others? 2. If you had to make the decision again, how likely would you be to undergo this surgery'? 3. Considering everything, how satisfied are you with the outcomes of your surgery? All of these questions will be answered by the patient in a paper and pencil form, using a 7-point response scale: very likely (or very satisfied) = 7; not at all likely (or not at all satisfied) = 1.

Time frame
One time at 12 months after crown delivery.

Other outcomes

Sponsors and contacts

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