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

Clinical and Radiographic Evaluation of Change in Labial Bone Thickness in Immediate Implant Placement In Maxillary Esthetic Zone Comparing a Jumping Gap of Less Than 2 mm to Equal or More Than 2 mm: A Non-randomized Clinical 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.

Study Overview

• Status: Recruiting
• Conditions: Jumping Gap; Guided Immediate Implant Placement; Labial Bone Thickness Change; Broken Down Tooth Rehabilitation
• Intervention / Treatment: Procedure: Immediate implant placement with jumping gap less than 2 mm; Procedure: Immediate implant placement with jumping gap equal to or more than 2 mm

Detailed Description

Tooth replacement with dental implants in the esthetic zone is often accompanied with esthetic complications such as mid-facial gingival recession, implant thread exposure and a concave contour. Various methods have been introduced to minimize the occurrence of such complications, including applying connective tissue grafts, grafting the jumping gap, performing immediate temporization and using surgical guides to ensure the placement of the implant in the optimal prosthetic position.(El Ebiary et al., 2023)

It would be beneficial to establish an evidence-based protocol for the jumping gap distance to follow through, with all immediate implants in the aesthetic zone, most of which have thin labial bone to begin with. Though there have been multiple studies conducted, specifically in the past few years, there is insufficient evidence that tells us what the optimal jumping gap is. (Hamilton et al., 2023) (Lambert et al., 2023).

Therefore, the aim of our study is to evaluate this survival rate and the amount of change in labial bone thickness that will result in different horizontal defect dimensions (HDD) ≤ 2 mm in comparison to the > 2 mm HDD.

The study will be conducted at the department of periodontology at the faculty of dentistry, Cairo University, Egypt. Patients will be selected from the outpatient clinic at the faculty of dentistry, Cairo University, Egypt. Patients screening will be carried out until the target sample is achieved.

Pre-operative phase:

Clinical evaluation:

1. An assessment of the patients' medical history and overall oral health will be conducted to ensure that it meets the study's eligibility requirements for participation.
2. Screening will then be done using periapical radiographs.
3. After patients are found eligible for enrolment, a Cone Beam Computed Tomography (CBCT) image will be taken to record the pre-operative bone level for the patient.
4. Following an in-depth description of the study's purpose and steps, the enrolled patients will have the opportunity to discuss with the researcher the informed consent.
5. The patients will sign a written informed consent form that has been translated into Arabic after they give their approval for the intervention and to follow the study process.
6. Impressions/digital scans will be taken for the patient in addition to the CBCT scan. A surgical guide will be fabricated and 3D-printed using model resin.

Radiographic examination:

A preoperative CBCT will be performed for patients who met the inclusion criteria to ensure their eligibility prior to surgery. (Joshi and Gupta, 2015)

Patient Preparation:

1. A full mouth supra and subgingival debridement (if needed) will be carried out for all recruited patients prior to surgery. Patients will be given oral hygiene instructions including brushing their teeth at least twice daily, in addition to rinse twice daily with 0.12% chlorohexidine mouthwash for two weeks.
2. Surgical treatment will not be scheduled until the patient demonstrates adequate plaque control (i.e., FMPS < 20% and FMBS ≤ 10%).
3. Patients will be prescribed pre-surgical prophylactic antibiotic (2 g of amoxicillin 1 h before surgery or Clindamycin 600 mg in case of allergy to penicillin). Additionally, the patient will be asked to rinse with chlorhexidine 0.2% mouth wash for 1 min at the start of the surgery. (Salgado-Peralvo et al., 2022)

Surgical phase:

1. Following the administration of local anesthesia, atraumatic extraction of the remaining root will be done using a 15C lancet and a periotome to sever the periodontal ligament then using forceps with rotatory motion to pull out the root(s). The integrity of remaining labial bone wall (≥ 1mm) will be checked prior to the drilling sequence of the implant placement.
2. In case of multiple roots; separation using a carbide surgical bur mounted on a high-speed handpiece will be carried out.
3. Debridement of any granulation tissue will be carried out thoroughly using a bone curette and the area will be flushed with saline.
4. A fully guided flapless implant placement protocol will then be followed according to the pre-planned dimensions in C.B.C.T.
5. Implants with internal conical connection will be placed at least 4 mm away from the gingival margin to be able to establish a decent emergence profile later on in the prosthetic phase.
6. Primary stability will be checked to be able to take the decision for placing a customized healing abutments attached to the implant in place. (ISQ ≥ 65)
7. Bone substitute biomaterial will be grafted in the horizontal defect distance 'jumping gap' created between the external surface of the implant and inner wall of the socket.
8. Customized healing collars will be inserted finally on the implants to cover the socket and stabilize the wound and graft material beneath.

Post-operative instructions:

1. Patients will continue to receive postoperative antibiotics for five days after surgery (Salgado-Peralvo et al., 2022)
2. Patients were instructed to follow oral hygiene measures and to use chlorhexidine 0.2% mouthwash for 2 weeks.
3. All patients will be clinically evaluated at 1 week and 2 weeks to make sure that the initial healing phase is going without complications.

Follow-up:

Each patient will be evaluated at 3, 6, 9 and 12 months post-operatively.

• Study Type: Interventional
• Enrollment (Estimated): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Cairo University
    • Contact: Isaac E Bastawros; Phone Number: +2 01004213926; Email: isaac.bastawros@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patients with a bounded single non-restorable upper tooth in the anterior maxilla (15-25) FDI (El Ebiary et al., 2023b)
2. Patients with an age range of 21 to 65 years old (Levine et al., 2022)
3. Patients with good oral hygiene with BoP ≤ 10 % (Chapple et al., 2018)
4. Compliant patients willing to follow up to one year.
5. Remaining labial bone thickness ≥ 1mm measured on C.B.C.T. and confirmed on the day of surgery after tooth extraction and before final implant placement.

Exclusion Criteria:

1. The presence of acute/active infection related to the non-restorable tooth (Block et al., 2009) cited in (Soegiantho et al., 2023)
2. Presence of labial bone defect as fenestration/dehiscence (Crespi et al., 2008) cited in (Soegiantho et al., 2023)
3. 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)
4. History of radiation to the maxilla (Cannizzaro et al., 2010) cited in (Soegiantho et al., 2023)
5. History of bisphosphonate therapy or other anti-resorptive agents (Cannizzaro et al., 2010) cited in (Soegiantho et al., 2023)
6. Uncontrolled systemic or metabolic disease. (Cecchinato et al., 2015) cited in (Soegiantho et al., 2023)
7. Patients with parafunctional habits or active periodontitis (Cannizzaro et al., 2010) cited in (Soegiantho et al., 2023) 8- Tobacco abuse (>10 cigarettes per day) (Canullo et al., 2010) cited in (Soegiantho et al., 2023)

9- Alcohol abuse (Block et al., 2009) cited in (Soegiantho et al., 2023)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Immediate implant placement with jumping gap less than 2 mm; surgically guided placement of a single immediate post-extraction implant in the upper aesthetic zone with a jumping gap < 2 mm.	Procedure: Immediate implant placement with jumping gap less than 2 mm; surgically guided placement of a single immediate post-extraction implant in the upper esthetic zone with a jumping gap ≥ 2mm.
Active Comparator: Immediate implant placement with jumping gap equal to or more than 2 mm; surgically guided placement of a single immediate post-extraction implant in the upper esthetic zone with a jumping gap ≥ 2mm.	Procedure: Immediate implant placement with jumping gap equal to or more than 2 mm; surgically guided placement of a single immediate post-extraction implant in the upper aesthetic zone with a jumping gap < 2 mm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Δ Labial bone thickness	It will be measured virtually using CBCT measurements, fusion of the C.B.C.Ts will be done.	Assessment at baseline and after 12 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Before implant placement and immediately after.
Crestal Bone Level	It will be measured using periapical radiographs in parallel technique for standardization comparing different bone levels.	Assessment at baseline, 3 months, 6 months, 9 months and 12 months.
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.	Assessment after final crown delivery (baseline), 3 months, 6 months, 9 months and 12 months.
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: Considering this was an elective operation, how likely would you be to recommend it to others?; If you had to make the decision again, how likely would you be to undergo this surgery'?; 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.	One time at 12 months after crown delivery.
Keratinized soft tissue width	It will be measured using a periodontal probe.	Assessment will be at the surgery day (baseline), 3 months, 6 months, 9 months and 12 months after crown delivery.
Keratinized soft tissue thickness	It will be measured using an anaesthetic needle with stopper + periodontal probe.	Assessment will be at the surgery day (baseline), 3 months, 6 months, 9 months and 12 months after crown delivery.

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2025
• Primary Completion (Estimated): June 18, 2028
• Study Completion (Estimated): June 18, 2028

Study Registration Dates

• First Submitted: March 29, 2026
• First Submitted That Met QC Criteria: March 29, 2026
• First Posted (Actual): April 3, 2026

Study Record Updates

• Last Update Posted (Actual): April 3, 2026
• Last Update Submitted That Met QC Criteria: March 29, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Immediate implant placement; Surgical guide; Jumping gap; Customized healing abutment; Accuracy of surgical guide
• Other Study ID Numbers: PER 28-1-2025

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No