Effect of Temporization on the Peri-implant Soft Tissue of Immediate Implants: Randomized Controlled Clinical Trial

NCT03970811 | Unknown

• 1 other identifier: MIU-IRB -1819-079
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Restoration, Temporary

Keywords

temporization immediate implants peri-implant soft tissue

Outcome Measures

Primary Outcomes (1)

• change in Pink Esthetic Score (PES)

  This will be performed by outcome assessor. PES is based on seven variables: mesial papilla, distal papilla, soft-tissue level, soft tissue contour, alveolar process deficiency, soft-tissue color and texture. Each variable will be assessed with a 2-1-0 score, with 2 being the best and 0 being the poorest score. The mesial and distal papilla will be evaluated for completeness, incompleteness or absence. All other variables will be assessed by comparison to a reference tooth (contralateral tooth).

  at 3, 6, 9 months

Secondary Outcomes (1)

• White Esthetic Score (WES)

  at 9 months

Other Outcomes (6)

• change in Gingival recession

  at 3, 6, 9 months

• change in Gingival thickness

  at 3, 6, 9 months

• change in Post-operative pain

  daily for 14 days, starting day of surgery

Study Arms (2)

Immediate implants with immediate temporization

EXPERIMENTAL

Immediate implants with simultaneous immediate placement of temporary crown and placement of the final restoration (loading) will be done 3 months postsurgical

Procedure: Immediate Implants; Procedure: temporary restoration; Procedure: final restoration

Immediate implants without temporization

ACTIVE COMPARATOR

Immediate implants without the use of temporary crown and placement of the final restoration (loading) will be done 3 months postsurgical

Procedure: Immediate Implants; Procedure: final restoration

Interventions

Immediate Implants PROCEDURE

dental implants are immediately placed after tooth extraction

Immediate implants with immediate temporization; Immediate implants without temporization

temporary restoration PROCEDURE

temporary restoration will be placed immediately after implant placement

Immediate implants with immediate temporization

final restoration PROCEDURE

final restoration (loading) will be placed 3 months postsurgical

Immediate implants with immediate temporization; Immediate implants without temporization

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Systemically free patients (American Society of Anesthesiologists I)
• Patients aged from 18 to 65 years old
• Buccal bone thickness should be at least 1mm assessed in CBCT
• Sinus floor or nasal floor clearance from root apex at least 4 mm as assessed in CBCT
• Good oral hygiene
• Accepts nine months follow-up period (cooperative patients)
• Patient accepts to provides an informed consent

You may not qualify if:

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

Sponsors & Collaborators

• Misr International University: lead
• Zinedent: collaborator

Study Sites (1)

Misr International university

Cairo, 11218, Egypt

Location

MeSH Terms

Interventions

Dental Restoration, Temporary

Intervention Hierarchy (Ancestors)

Dental Prosthesis; Prosthodontics; Dentistry; Prostheses and Implants; Equipment and Supplies

Study Officials

• Shahinaz G Elashiry, Assoc. Prof.

  Periodontics Dep., Faculty of Dentistry, Misr International University

  PRINCIPAL INVESTIGATOR

• Hani El-Nahass, Assoc. Prof.

  Periodontics Dep., Faculty of Dentistry, Cairo University

  STUDY DIRECTOR

• Fatma H Eldemerdash, Lecturer

  Periodontics Dep., Faculty of Dentistry, Misr International University

  STUDY CHAIR

• Talaat Samhan, Lecturer

  Fixed Prosthodontic Div., Faculty of Dentistry, Misr International University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: May 25, 2019
• First Posted: June 3, 2019
• Study Start: August 8, 2019
• Primary Completion: August 31, 2022
• Study Completion: December 22, 2022
• Last Updated: January 10, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)