Evaluating and comparing the clinical and radiographic aspects of immediate implant in mandibular teeth with and without allograft
Design
Simple randomized 2-3 phase clinical trial with parallel groups in a single-blind fashion on 30 patients.
Settings and conduct
The hospital of the Mashhad University of Medical Sciences
Participants/Inclusion and exclusion criteria
Including criteria:
Patients in the need of implant surgery.
Patients with at least 2 mm width of keratinized gum across the hopeless tooth.
Patients with at least 2 mm of the buccal implant to the internal side of the buccal bone distance.
Excluding criteria:
Patients with periodontitis in the hopeless region of the tooth.
Patients that after extracting the hopeless tooth will experience dehiscence and fenestration in the extraction site.
Intervention groups
Intervention group: Implanting will be performed by local anesthesia. The teeth extraction is being performed by atraumatic and by removing the roots first to maintain the bony filament. After extraction, the best region for implantation is chosen. According to the implant manufacturer, the place would be drilled and then, the implant will be inserted and closed to the area with healing. At last, the grafting material would be added.
Control group: Implanting will be performed by local anesthesia. The teeth extraction is being performed by atraumatic and by removing the roots first to maintain the bony filament. After extraction, the best region for implantation is chosen. According to the implant manufacturer, the place would be drilled and then, the implant will be inserted and closed to the area with healing. At last, no material would be added.
Main outcome variables
Bone degeneration
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220108053669N2
Registration date:2022-04-22, 1401/02/02
Registration timing:prospective
Last update:2022-04-22, 1401/02/02
Update count:0
Registration date
2022-04-22, 1401/02/02
Registrant information
Name
Peyman Esmaeili Fard Barzegar
Name of organization / entity
Lorestan University
Country
Iran (Islamic Republic of)
Phone
+98 21 4411 3043
Email address
esmaeili.pe@fv.lu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-22, 1401/04/01
Expected recruitment end date
2022-09-23, 1401/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The evaluation and comparin gthe clinical and radiographic immediate implant in mandibular molar teeth with and without grafting materials
Public title
The evaluation of immediate implant in molar teeth
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The patients who need implant surgery
The patients with hopeless peritooth keratinized gum width of more than 2 mm.
The patients whose implant buccal distance to the internal surface of buccal bone is more than 2 mm.
Exclusion criteria:
The patients who are suffering from periodontitis in the hopeless region.
the patients who after extracting the hopeless tooth suffered from dehiscence or fenestration in extraction region
Age
From 22 years old to 58 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomized, in which all patients who were referred to this hospital and had the including criteria, were completely randomly entered and examined statistically until the number reached the desired patients.
Blinding (investigator's opinion)
Single blinded
Blinding description
The patients in both groups were unaware of the kind of material used (Single-blind), but the nurse who administered the drug and the scientists were aware of the contained drug.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences
Street address
Knowledge and Health City - In the end of Shahid Fakouri Blvd (In the front of Fakouri 94)
City
Mashhad
Province
Razavi Khorasan
Postal code
99191-91778
Approval date
2019-10-05, 1398/07/13
Ethics committee reference number
IR.MUMS.DENTISTRY.REC.1399.068
Health conditions studied
1
Description of health condition studied
tooth Implant
ICD-10 code
Z96.5
ICD-10 code description
Presence of tooth-root and mandibular implants
Primary outcomes
1
Description
Pocket depth
Timepoint
After implanting, 3 months after surgery and 3 months after loading.
Method of measurement
It is evaluated clinically
2
Description
Bleeding on probing (BOP)
Timepoint
After implanting, 3 months after surgery and 3 months after loading.
Method of measurement
It is evaluated clinically.
3
Description
The distance between bone and border of implant
Timepoint
After implanting, 3 months after surgery and 3 months after loading.
Method of measurement
With the help of radiograph.
4
Description
The thickness of keratinized gum.
Timepoint
After implanting, 3 months after surgery and 3 months after loading.
Method of measurement
Clinically
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Implanting will be performed by local anesthesia. The teeth extraction is being performed by atraumatic and by removing the roots first to maintain the bony filament. After extraction, the best region for implantation is chosen. According to the implant manufacturer, the place would be drilled and then, the implant will be inserted and closed to the area with healing. At last, the grafting material would be added.
Category
Treatment - Drugs
2
Description
Control group: Implanting will be performed by local anesthesia. The teeth extraction is being performed by atraumatic and by removing the roots first to maintain the bony filament. After extraction, the best region for implantation is chose. According to the implant manufacturer, the place would be drilled and then, the implant will be inserted and closed to the area with healing. At last, no material would be added.