To compare soft tissue healing regarding cover screw exposure on 7th post op day and pink esthetic score on 3rd and 6th post op month in immediate implant placement in fresh extraction socket with and without the use of platelet rich fibrin.
Design
A Prospective, Randomized Controlled clinical trial with a parallel group design of 60 patients, enrolled between 20th January 2021 to 19th October 2021 and followed for 8 months
Settings and conduct
Department of Oral and Maxillofacial Surgery, AFID Rawalpindi.
Participants/Inclusion and exclusion criteria
Inclusion crieteria: min age 18-60 years old, presence of Maxillary and mandibular teeth without active infection, with healthy surrounding tissue
Exclusion crieteria: edentulous patients, patients having diabetes, undergoing chemotherapy, radiotherapy, habit of smoking
Intervention groups
Intervention group shows stimulation and acceleration of bone regeneration and show tendency toward rapid soft tissue regeneration and reduced peri-implant pain and inflammation as compared to controlled group.
Main outcome variables
Quantitative variables like age will be measured as mean ± Standard deviation SD. Qualitative variables like Gender, Cover screw exposure at 7th post op day and Pink esthetic score at 3rd and 6th month follow up will be measured as frequency and percentage. Chi-Square test will be applied to compare qualitative variables like Cover screw exposure on 7th post op day and Pink esthetic score after 3 and 6 months follow up between two groups
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230714058773N1
Registration date:2023-09-02, 1402/06/11
Registration timing:retrospective
Last update:2023-09-02, 1402/06/11
Update count:0
Registration date
2023-09-02, 1402/06/11
Registrant information
Name
Tehmina Maryam
Name of organization / entity
Armed forces institute of dentistry, combined military hospital, Rawalpindi, Pakistan
Country
Pakistan
Phone
+92 333 9576737
Email address
tehminamaryam@hotmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-20, 1399/11/01
Expected recruitment end date
2021-10-19, 1400/07/27
Actual recruitment start date
2021-01-20, 1399/11/01
Actual recruitment end date
2021-10-19, 1400/07/27
Trial completion date
2021-10-20, 1400/07/28
Scientific title
Comparison of Soft Tissue Healing in Immediate Implant Placement in Fresh Extraction Socket with and without the Use of Platelet-Rich Fibrin
Public title
Comparison of Soft Tissue Healing in Immediate Implant Placement in Fresh Extraction Socket with and without the Use of Platelet-Rich Fibrin
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Presence of maxillary or mandibular tooth
Tooth indicated for extraction without any active infection
Presence of adequate and harmonious gingival architecture with the surrounding dentition
Adequate bone volume bone height and width
Good oral hygiene
Exclusion criteria:
Edentulous Patients . .
Patients on chemotherapy
Patients on radiotherapy
Systemic diseases such as diabetes
Habit of Smoking
Any active infection surrounding tooth indicated for extraction
Poor oral hygiene
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of armed forces institute of dentistry CMH Rawalpindi
Will be measured as frequency and percentage. Chi-Square test will be applied to compare qualitative variable like Cover screw exposure on 7th post op day between two groups
2
Description
Pink esthetic score
Timepoint
3rd and 6th month after intervention
Method of measurement
Will be measured as frequency and percentage. Chi-Square test will be applied to compare qualitative variable like Pink esthetic score after 3 and 6 months follow up between two groups
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 30 Patients selected according to inclusion criteria i.e Minimum age 18-60 years, presence of maxillary or mandibular tooth, tooth indicated for extraction without any active infection, presence of adequate and harmonious gingival architecture with the surrounding dentition, adequate bone volume bone height and width, good oral hygiene, immediate implant placement was done after extraction with the use of platelet rich-fibrin. Patients instructed to revisit for follow up on 7th day to evaluate Cover screw exposure. And after 3 and 6 months they checked for Pink esthetic score.
Category
Treatment - Surgery
2
Description
Control group: 30 Patients selected according to inclusion criteria i.e Minimum age 18-60 years, presence of maxillary or mandibular tooth, tooth indicated for extraction without any active infection, presence of adequate and harmonious gingival architecture with the surrounding dentition, adequate bone volume bone height and width, good oral hygiene, immediate implant placement was done after extraction without the use of platelet rich-fibrin. Patients instructed to revisit for follow up on 7th day to evaluate Cover screw exposure. And after 3 and 6 months they checked for Pink esthetic score.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Armed forces institute of dentistry CMH ,Rawalpindi ,Pakistan
Full name of responsible person
Tehmina Maryam
Street address
Range road Rawalpindi
City
Rawalpindi
Postal code
46000
Phone
+92 333 9576737
Email
tehminamaryam27@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Armed forces institute of dentistry CMH Rawalpindi
Full name of responsible person
Nazir Khan
Street address
Range road Rawalpindi
City
Rawalpindi
Postal code
46000
Phone
+92 333 2353267
Email
nazeerkhan996@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Armed forces institute of dentistry CMH Rawalpindi
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Armed forces institute of dentistry, combined military hospital, Rawalpindi, Pakistan
Full name of responsible person
Tehmina Maryam
Position
Final year registrar
Latest degree
Bachelor
Other areas of specialty/work
Oral and maxillofacial surgery
Street address
AMC officers mess opposite to AFIMH gate no 5 abid majeed road Rawalpindi
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 333 9576737
Fax
Email
tehminamaryam@hotmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Armed forces institute of dentistry, combined military hospital, Rawalpindi, Pakistan
Full name of responsible person
Tehmina Maryam
Position
Final year registrar
Latest degree
Bachelor
Other areas of specialty/work
Oral and maxillofacial surgery
Street address
AMC officers mess opposite to AFIMH gate no 5 abid majeed road Rawalpindi
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 333 9576737
Fax
Email
tehminamaryam@hotmail.com
Person responsible for updating data
Contact
Name of organization / entity
Armed forces institute of dentistry CMH Rawalpindi
Full name of responsible person
Tehmina Maryam
Position
Registrar
Latest degree
Bachelor
Other areas of specialty/work
Oral and maxillofacial surgery
Street address
Range road Rawalpindi
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 333 9576737
Email
Tehminamaryam27@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD