Dental Restoration, TemporaryNCT03970811
Effect of Temporization on the Peri-implant Soft Tissue of Immediate Implants: Randomized Controlled Clinical Trial
A study testing Immediate Implants, temporary restoration and final restoration in people with Dental Restoration, Temporary, run by Misr International University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Restoration, Temporary
- What is being tested?
- Immediate Implants, temporary restoration and final restoration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteEgypt
- Study dates
- 8 Aug 2019to 22 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of the Effect of Temporization on the Peri-implant Soft Tissue of Immediate Implants: A Randomized Controlled Clinical Trial
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.
Read the detailed description
- Intervention:
- 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).
- Clinical examination and preoperative evaluation using Cone Beam Computed Tomography (CBCT) (Recruitment):
- 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.
- Evaluation of the soft tissue biotype by trans-gingival piercing using a periodontal probe.
- 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)
- 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.
- 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
- 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.
- 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.
- 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.
- Postoperative Care:
- Antibiotics (Amoxicillin 1g orally- twice daily for 5 days).
- Anti-inflammatory drugs (NSAIDS; Ibuprofen 600mg three times daily after meals for 5 days).
- Antiseptic mouthwash (0.12% Chlorhexidine) will be prescribed for 60 seconds, 15 ml each time, two times a day for 14 days.
- 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.
- 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.
- Conditions
- Dental Restoration, Temporary
- Being tested
- Immediate Implants, temporary restoration, final restoration
- Keywords
- temporization immediate implants peri-implant soft tissue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate ImplantsProcedure or surgery
dental implants are immediately placed after tooth extraction
temporary restorationProcedure or surgery
temporary restoration will be placed immediately after implant placement
final restorationProcedure or surgery
final restoration (loading) will be placed 3 months postsurgical
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: Immediate Implants; Procedure: final restoration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: at 3, 6, 9 months
Secondary outcomes (1)
White Esthetic Score (WES)
This will be performed by outcome assessor. WES focuses on the visible part of the implant restoration based on five parameters: general tooth form, outline, clinical crown volume, color including (hue and value), surface texture, translucency and characterization. a score of 2,1,0 is assigned to the five parameters. All the five parameters will be assessed by direct comparison with the contralateral reference tooth.
Measured: at 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2019
- Study start8 Aug 2019
- Primary completion31 Aug 2022 (estimated)
- Study completion22 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Restoration, TemporaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Misr International University
- Sponsor type
- University, hospital or other
- Collaborators
- Zinedent
- Responsible party
- Principal investigator, Shahinaz Elashiry, Misr International University
- Investigators
- Shahinaz G Elashiry, Assoc. Prof., Principal investigator, Periodontics Dep., Faculty of Dentistry, Misr International UniversityHani El-Nahass, Assoc. Prof., Study director, Periodontics Dep., Faculty of Dentistry, Cairo UniversityFatma H Eldemerdash, Lecturer, Study chair, Periodontics Dep., Faculty of Dentistry, Misr International UniversityTalaat Samhan, Lecturer, Study chair, Fixed Prosthodontic Div., Faculty of Dentistry, Misr International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03970811
- Sponsor's protocol ID
- MIU-IRB -1819-079
- Status last verified
- Jan 2022
- First submitted
- 25 May 2019
- Last updated
- 10 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Effect of Temporization on the Peri-implant Soft Tissue of Immediate Implants: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03970811
- Acronym / sponsor ID
- MIU-IRB -1819-079
- Conditions
- Dental Restoration, Temporary
- Keywords
- temporization immediate implants peri-implant soft tissue
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Misr International UniversityUniversity, hospital or other
- Collaborators
- Zinedent
- Study start
- 8 Aug 2019 (actual)
- Primary completion
- 31 Aug 2022 (estimated)
- Study completion
- 22 Dec 2022 (estimated)
- First posted
- 3 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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).
- Clinical examination and preoperative evaluation using Cone Beam Computed Tomography (CBCT) (Recruitment):
- 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.
- Evaluation of the soft tissue biotype by trans-gingival piercing using a periodontal probe.
- 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)
- 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.
- 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
- 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.
- 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.
- 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.
- Postoperative Care:
- Antibiotics (Amoxicillin 1g orally- twice daily for 5 days).
- Anti-inflammatory drugs (NSAIDS; Ibuprofen 600mg three times daily after meals for 5 days).
- Antiseptic mouthwash (0.12% Chlorhexidine) will be prescribed for 60 seconds, 15 ml each time, two times a day for 14 days.
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Immediate implants with immediate temporization | Experimental | Procedure: Immediate Implants, Procedure: temporary restoration, Procedure: final restorationImmediate implants with simultaneous immediate placement of temporary crown and placement of the final restoration (loading) will be done 3 months postsurgical |
| Immediate implants without temporization | Active comparator | Procedure: Immediate Implants, Procedure: final restorationImmediate implants without the use of temporary crown and placement of the final restoration (loading) will be done 3 months postsurgical |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immediate Implantsdental implants are immediately placed after tooth extraction | Procedure or surgery | Immediate implants with immediate temporization, Immediate implants without temporization |
| temporary restorationtemporary restoration will be placed immediately after implant placement | Procedure or surgery | Immediate implants with immediate temporization |
| final restorationfinal restoration (loading) will be placed 3 months postsurgical | Procedure or surgery | Immediate implants with immediate temporization, Immediate implants without temporization |
Primary outcome
change in Pink Esthetic Score (PES)
Time frame: at 3, 6, 9 months
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).
1 secondary outcome
White Esthetic Score (WES)
Time frame: at 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shahinaz G Elashiry, Assoc. Prof. principal investigator
Periodontics Dep., Faculty of Dentistry, Misr International University
Hani El-Nahass, Assoc. Prof. study director
Periodontics Dep., Faculty of Dentistry, Cairo University
Fatma H Eldemerdash, Lecturer study chair
Periodontics Dep., Faculty of Dentistry, Misr International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate Implants, temporary restoration and final restoration in people with Dental Restoration, Temporary, run by Misr International University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in Pink Esthetic Score (PES) (time frame: at 3, 6, 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2022.