Clinical trial NCT03970811: Effect of Temporization on the Peri-implant Soft Tissue of Immediate Implants: Randomized Controlled Clinical Trial
Official title: Clinical Evaluation of the Effect of Temporization on the Peri-implant Soft Tissue of Immediate Implants: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Restoration, Temporary
Keywords: temporization immediate implants peri-implant soft tissue
Lead sponsor: Misr International University
Sponsor class: OTHER
Collaborators: name: Zinedent
First posted: 2019-06-03
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This parallel arms, randomized controlled clinical trial will involve 22 systemically free patients with an unrestorable tooth in the upper esthetic zone. They will be randomly allocated to two equal groups. Group A (test group) will receive immediate implants with simultaneous immediate temporization, while group B (control group) will receive immediate implants with no temporization.
Primary purpose: TREATMENT

Brief summary: This parallel arms, randomized controlled clinical trial will involve 22 systemically free patients with an unrestorable tooth in the upper esthetic zone. They will be randomly allocated to two equal groups. Group A (test group) will receive immediate implants with simultaneous immediate temporization, while group B (control group) will receive immediate implants with no temporization. After scaling root planing, the clinical parameters including PES, gingival recession, gingival thickness, postoperative pain and swelling as well as radiographic parameter obtained from Cone Beam Computed Tomography (CBCT) (buccal bone thickness) will be recorded. Immediate implant placement will be performed followed by simultaneous temporization in group A only. Postoperative medication will be prescribed to the patient and postoperative instructions will be explained in detail. Monthly follow-up will be performed to ensure performing proper oral hygiene. Data will be recorded at baseline (at time of implant insertion), three months, six months and nine months post prosthetic placement. Data collected will be tabulated and statistically analysed.

Detailed description: • Intervention:

1. Calibration process: Before beginning the study, outcome assessment will be calibrated. Outcome assessment will be performed by Co-investigator-II and Principal investigator. The calibration process will be repeated until each investigator has substantial correlation as measured by Cohen's Kappa (k ≥ 0.6).
2. Clinical examination and preoperative evaluation using Cone Beam Computed Tomography (CBCT) (Recruitment):

   1. Evaluation of the patient's general condition of the oral cavity, to make sure it complies with the criteria required to be enrolled in the study in terms of oral hygiene, pathological conditions, occlusion and inter-arch space.
   2. Evaluation of the soft tissue biotype by trans-gingival piercing using a periodontal probe.
   3. Width of keratinized gingiva in millimeters (measured by a periodontal probe from the gingival margin to the mucogingival junction). It is measured at three areas (mesial, mid buccal and distal)
   4. A preoperative CBCT will be performed for all patients before enrollment as a standard procedure. Evaluation and recording of the periapical condition, crestal bone level, available buccal bone thickness (not less than one millimeter), bucco-palatal bone width, height and density. Suitable implant length and diameter will be determined as well.

   Patients with all inclusion criteria will be offered to participate in the study and sign a consent form.
3. Random allocation: After consenting, each patient will be allocated in one of the two study groups randomly using random numbers generated by rand.org created and kept by a teaching assistant not participating in the study. Grouping will be as follows:

   * Group A (test group): Immediate implants placed with simultaneous immediate temporization (Immediate Implants + Immediate Temporization).
   * Group B (control group): Immediate implants only
4. Allocation concealment: It will achieved using a sealed coded opaque envelopes containing treatment of the subject. They will be kept by the teaching assistant. The envelope will be handed to the principal investigator and opened just before performing the surgical procedure.
5. Blinding: blinding of investigators, outcome assessors and participants cannot be achieved due to the presence of a temporary crown in test group immediately after implant placement while being absent in the control group.
6. Surgical procedure:

   Surgical procedures will be carried out by Co-invesigator-I. Following the administration of local anesthesia, atraumatic extraction will be done using a remaining root or anterior forceps.

   After proper curettage of the socket wall using a small bone curette to remove any granulation tissue, implant insertion is performed according to manufacturer's instructions as follows:
   * A point of entrance for the drills will be created using a surgical round bur.
   * Drills will be used sequentially until the required implant diameter is reached.
   * Implant insertion will be done in the osteotomy site using a torque wrench by self-tapping fashion till the implant is leveled about two mm apical to the alveolar bone crest with adequate primary stability (torque above 35N).
   * After implant placement, a periapical radiograph using a radiographic holder and a radiographic stent will be taken to determine the crestal bone level. The parallel technique in combination with the acrylic stent will be used to ensure reproducibility.

   As regards the control Group (Group B), no temporization is needed. Implant exposure and subsequent prosthetic placement of the final restoration (loading) will be performed 3 months postsurgical. As for the test group (Gp A), temporization procedures will be done immediately after implant placement utilizing a temporary abutment supplied by the manufacturer which will be scanned once placed using an intraoral scanner \[Dentsply blue cam\]. Designing will be performed using Inlab premium 4.4 software. Milling of the provisional crowns will done using CEREC \[Dentsply\] with estimated milling time of 25 minutes per crown. Polymethylmethaacrylate (PMMA) blanks will be used to fabricate the provisional crowns. Crowns will be finished and polished by Soflex finishing and polishing kits. Adequate emergence profile, marginal fit, occlusion and esthetics will be confirmed and the occlusion will refined using medium then fine articulating paper. Final repolishing is mandatory to ensure absence of gingival inflammation.
7. Postoperative Care:

   1. Antibiotics (Amoxicillin 1g orally- twice daily for 5 days).
   2. Anti-inflammatory drugs (NSAIDS; Ibuprofen 600mg three times daily after meals for 5 days).
   3. Antiseptic mouthwash (0.12% Chlorhexidine) will be prescribed for 60 seconds, 15 ml each time, two times a day for 14 days.
   4. Patient self-care instructions:

      * Application of an ice bag to the treated area for the first 24 hours.
      * Gently brushing the operated area starting from the second day with a soft brush using roll technique.
8. Follow-up: Patients' recall visits will be scheduled every month for supportive periodontal therapy and recording of outcome variables at three, six and nine months.

Eligibility criteria: Inclusion Criteria:

1. Patients who have at least one unrestorable tooth in the upper esthetic zone (anterior teeth and premolars) that need to be extracted with sound neighboring teeth
2. Systemically free patients (American Society of Anesthesiologists I)
3. Patients aged from 18 to 65 years old
4. Buccal bone thickness should be at least 1mm assessed in CBCT
5. Sinus floor or nasal floor clearance from root apex at least 4 mm as assessed in CBCT
6. Good oral hygiene
7. Accepts nine months follow-up period (cooperative patients)
8. Patient accepts to provides an informed consent

Exclusion Criteria:

1. Patients with signs of acute infection related to the area of interest or any pathological lesions that affect healing
2. Patients with habits that may jeopardize the implant longevity and affect the results of the study such as parafunctional habits such as bruxism
3. Smokers
4. Pregnant and lactating females

Primary outcomes:
measure: change in Pink Esthetic Score (PES)
timeFrame: at 3, 6, 9 months
Secondary outcomes:
measure: White Esthetic Score (WES)
timeFrame: at 9 months
Other outcomes:
measure: change in Gingival recession
timeFrame: at 3, 6, 9 months
measure: change in Gingival thickness
timeFrame: at 3, 6, 9 months
measure: change in Post-operative pain
timeFrame: daily for 14 days, starting day of surgery
measure: change in Post-operative swelling
timeFrame: daily for 7 days, starting day of surgery
measure: change in Buccal bone thickness at different levels
timeFrame: presurgical (for inclusion in the study), at 9 months
measure: Patient satisfaction
timeFrame: at 9 months
Locations:
city: Cairo
country: Egypt
facility: Misr International university
Study officials:
affiliation: Periodontics Dep., Faculty of Dentistry, Misr International University
name: Shahinaz G Elashiry, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Periodontics Dep., Faculty of Dentistry, Cairo University
name: Hani El-Nahass, Assoc. Prof.
role: STUDY_DIRECTOR
affiliation: Periodontics Dep., Faculty of Dentistry, Misr International University
name: Fatma H Eldemerdash, Lecturer
role: STUDY_CHAIR
affiliation: Fixed Prosthodontic Div., Faculty of Dentistry, Misr International University
name: Talaat Samhan, Lecturer
role: STUDY_CHAIR
References: