Immediate Implant Placement With Sticky Tooth Versus Autogenous Tooth Graft In Cases With Labial Plate Dehiscence

September 3, 2023 updated by: Halla Gamal Mohammed Esmail

Evaluation of Soft and Hard Tissue Changes After Immediate Implant Placement With Sticky Tooth Versus Autogenous Tooth Graft In Cases With Labial Plate Dehiscence: A 1-Year Randomized Clinical Trial

Evaluation of Soft and Hard Tissue Changes After Immediate Implant Placement With Sticky Tooth Versus Autogenous Tooth Graft for management of Cases With Labial Plate Dehiscence

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In patients with labial plate dehiscence in the esthetic zone, there is no difference between the use of tooth-derived granules in combination with platelet-rich fibrin ("sticky tooth") and autogenous tooth graft in conjunction with immediate implant placement in enhancing the amount of bone labial to the implant

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Non-restorable teeth in the esthetic zone with a defect of labial bone.

    • Teeth with no acute inflammation.
    • Patients are free from any systemic condition that may affect the healing.
    • Availability of bone apical and palatal to the socket to provide primary stability
    • Good oral health.
    • Willingness to sign the informed consent form.

Exclusion Criteria:

  • Heavy smoker (> 10 cigarettes/day)
  • Pregnant females
  • Contraindication for Implant surgery.
  • Patients with poor oral hygiene.
  • Acute inflammation in the site of implantation and adjacent tissue.
  • A history of radiotherapy in the head or neck region.
  • Patients with systemic diseases like uncontrolled diabetes mellitus, coagulation disorders, alcohol or drug abuse not suitable for implantation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention group

sticky tooth preparation:

  • patient's venous blood will be collected using a 21 g needle with a butterfly handle.
  • The blood in the test tubes will be centrifuged at 700 rpm for 3 min for women and 4 min for men because of a different hematocrit.
  • The liquid PRF fraction will be collected using a sterile syringe. It gently will be mixed with the demineralized dentin granules and allowed for five-ten minutes for polymerization in order to produce a sticky tooth.
Procedure: immediate implant augmented with sticky tooth
  • Topical anesthesia will be administered using an infiltration technique.
  • Atraumatic extraction will be done with the aid of periotome and Luxators.
  • The extraction socket will be debrided to remove any residual debris or granulation tissue.
  • Full-thickness midcrestal incision and vertical releasing incision on the distal side will be made, and a vertical releasing incision on the mesial side will be made if necessary. The extraction socket and the labial bone defect will be exposed by buccal and palatal flap reflection.
  • Implant insertion will be performed according to the manufacturer's instruction, and then the implant will be inserted 2mm apical to the alveolar bone crest with adequate primary stability.
  • The gap between the implant and the defect of the facial bone will be filled with the sticky tooth to reach enough buccal bone supported and then will be covered with absorbable barrier collagen membranes.
  • Finally, the flap will be repositioned and sutured.
Active Comparator: Control group

Autogenous demineralized dentin graft preparation

  • Extracted teeth will be cleaned from periodontal ligaments, cementum, soft tissue attachment, caries, or restorations (if present), using a high-speed fine finishing stone and saline irrigation.
  • The pulp will be removed, using a root canal instrument. Subsequently, the remaining dentin will be cut into pieces. These pieces of dentin will be ground using a bone mill to produce dentin particles.
  • The sorted particles will be immersed in 70% ethanol and 4% H2O2 in a sterile container to remove any soft tissue remnants, bacteria, and smear layer.
  • Tooth particles will be demineralized using 0.6N HCl for 30 minutes to expose the dentine organic matrix.
  • After demineralization, the materials will be washed with phosphate-buffered saline (PBS) and dried with sterile gauze.
Procedure: immediate implant augmented with autogenous tooth graft
  • Topical anesthesia will be administered using an infiltration technique.
  • Atraumatic extraction will be done with the aid of periotome and Luxators.
  • The extraction socket will be debrided to remove any residual debris or granulation tissue.
  • Full-thickness midcrestal incision and vertical releasing incision on the distal side will be made, and a vertical releasing incision on the mesial side will be made if necessary. The extraction socket and the labial bone defect will be exposed by buccal and palatal flap reflection.
  • Implant insertion will be performed according to the manufacturer's instruction, and then the implant will be inserted 2mm apical to the alveolar bone crest with adequate primary stability.
  • The gap between the implant and the defect of the facial bone will be filled with the autogenous demineralized dentin graft to reach enough buccal bone supported and then will be covered with collagen membranes.
  • Finally, the flap will be repositioned and sutured.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Radiographic width of bone labial to the implant
Time Frame: 1 year
Amount of bone labial to the implant will be measured perpendicular to the vertical line of the implant surface at the implant neck level or the top of the buccal bone (which is regarded as 0 mm), 3 mm and 6 mm apical to the implant neck Each measurement will be recorded at different times
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Radiographic horizontal bucco-palatal bone changes
Time Frame: 1 year
The bucco-palatal width of the alveolar bone will be measured perpendicular to the long axis of the alveolar bone; the 3 measurements will be the coronal width (CW), middle width (MW), and apical width (AW). Each measurement will be recorded at different times
1 year
Radiographic vertical bone changes
Time Frame: 1 year
Vertical bone height will be measured. Measurement will be taken at highest point of the remaining labial/buccal plate of bone using the implant neck as a reference point. Each measurement will be recorded at different times and the difference between pre and post-operative measurements will be determined as the gain in labial/buccal vertical bone dimension
1 year
Esthetic evaluation (The pink esthetic score)
Time Frame: 1 year
The pink esthetic score will be calculated on the parameters defined by (Fürhauser et al. 2005). Clinical photographs will be taken to evaluate peri-implant soft tissue through evaluating seven variables compared to a natural reference tooth including: mesial papilla, distal papilla, soft-tissue level, soft-tissue contour, alveolar process deficiency, soft-tissue color and texture. Using a 0-1-2 scoring system, 0 being the lowest, 2 being the highest value. The maximum achievable PES is 14.
1 year
Implant stability
Time Frame: 6 months
Implant stability will be measured using Ostell which has a scale ranges from 1 to 100, the higher the ISQ the more stability
6 months
Gingival Thickness
Time Frame: 1 year
Gingival thickness will be evaluated 2 mm below the gingival margin with a short needle for and silicon disk stop. The needle will be inserted perpendicular to the mucosal surface, through the soft tissues with light pressure until a hard surface was reached. The silicone disc stop was then mounted in close contact with the gingival tissue surface. The insertion depth was assessed with a digital caliper accurate to the nearest 0.1 mm
1 year
Width of the Keratinized Tissue
Time Frame: 1 year
It will be evaluated from the gingival margin to the mucogingival junction (MGJ). The MGJ was assessed with roll technique
1 year
Midfacial recession
Time Frame: 1 year
Corono-apical distance between the peri-implant soft tissue margin and the cemento-enamel junction (CEJ) of the homologous contralateral tooth
1 year
Post-Operative Pain
Time Frame: 7 days
Pain will be assessed post-surgically using the Visual Analogue Scale (VAS) with numbers from 0 to 10 score zero represented no pain while score 10 represented the worst pain imaginable
7 days
Post-Operative patient's Satisfaction
Time Frame: 1 year

Three Yes or No Questions will be asked to the patient about his overall satisfaction about the procedure

/
1 year
Post-operative swelling
Time Frame: 7 days

Swelling will be assessed post-surgically using the Verbal Rating Scale (VRS) (García et al. 2008):

  • Absent (no swelling),
  • Slight (intraoral swelling at the operated area),
  • Moderate (moderate intraoral swelling at the operated area) and
  • Intense (intensive extraoral swelling extending beyond the operated area)
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Halla Gamal Mohammed Esmail

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 27, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 27, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 7, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 7, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 3, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023 (GRAMMY Museum Foundation)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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