| CTRI Number |
CTRI/2026/03/106406 [Registered on: 17/03/2026] Trial Registered Prospectively |
| Last Modified On: |
17/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to evaluate effects of i-PRF and Collaplug PRF with and without laser photobiomodulation for alveolar socket preservation. |
|
Scientific Title of Study
|
Comparative Evaluation of I- PRF and Collaplug With or Without Laser Photobiomodulation in Alveolar Socket Preservation. |
| Trial Acronym |
Not applicable |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr M Rukmini Jyothirmayee |
| Designation |
Associate Professor |
| Affiliation |
Sibar Institute of Dental Sciences |
| Address |
Department of Periodontology
Sibar Institute of Dental Sciences,
Takkellapadu, Guntur, Andhra Pradesh.
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9491358446 |
| Fax |
|
| Email |
mrj1329@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepa A |
| Designation |
Professor |
| Affiliation |
Sibar Institute of Dental Sciences |
| Address |
Department of Periodontology
Sibar Institute of Dental Sciences,
Takkellapadu, Guntur, Andhra Pradesh.
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9618501146 |
| Fax |
|
| Email |
anumala.deepas@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr M Rukmini Jyothirmayee |
| Designation |
Associate Professor |
| Affiliation |
Sibar Institute of Dental Sciences |
| Address |
Department of Periodontology
Sibar Institute of Dental Sciences,
Takkellapadu, Guntur, Andhra Pradesh.
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9491358446 |
| Fax |
|
| Email |
mrj1329@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sibar Institute of Dental sciences, Takkellapadu, Guntur, Andhra Pradesh - 522509 |
|
|
Primary Sponsor
|
| Name |
Dr. M. Rukmini Jyothirmayee |
| Address |
Dr. M. Rukmini Jyothirmayee
Associate Professor,
Department of Periodontology
Sibar Institute of Dental Sciences
Takkellapadu Guntur Andhra Pradesh 522509
|
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr M Rukmini Jyothirmayee |
Sibar Institute of Dental Sciences |
Department of Periodontology, Room no:08, Sibar Institute of Dental Sciences, Takkellapadu, Guntur, Andhra Pradesh, India - 522509
Guntur
ANDHRA PRADESH |
09491358446
mrj1329@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee-SIBAR Institute of Dental Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Alveolar socket after tooth extraction |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Alveolar Socket Preservation with i-PRF and Collaplug |
Atraumatic extraction:
Atraumatic tooth extraction will be performed under local anesthesia using lidocaine 2% with 1:100000 epinephrine using periotome. After removing the tooth, careful degranulation of extraction socket will be performed using bone curettes and sterile saline. Evaluation of the bone, especially buccal bone, at the extraction site was performed gently using a periodontal probe.
i-PRF preparation:
The patient provided 9–10 mL of blood. After blood collection, we placed the blood in plain tubes, added no additional anti-coagulant, and immediately centrifuged each blood sample for 3 min at 800 rpm (60× g). As a result, three layers will be formed in the tube. The top layer is acellular plasma/platelet-poor plasma (PPP), the bottom layer is RBC concentrates, and the centre layer is orange coloured i-PRF which is carefully aspirated with sterile syringe and infused into collaplug.
In the Control group, i-PRF and collaplug at the extraction site along with figure eight sutures will be placed.
A postoperative pain assessment was performed 24 h, 3 days, and 7 days later and suture removal will be done at day 7.
The patient will be recalled after three months follow-up, where second CBCT examination will be taken
Ridge height, ridge width and bone density will be evaluated at baseline and after 3 months through CBCT.
|
| Intervention |
Intervention – Alveolar Socket Preservation with i-PRF and Collaplug with Laser
Photobiomodulation
|
Atraumatic extraction:
Atraumatic tooth extraction will be performed under local anesthesia using lidocaine 2% with 1:100000 epinephrine using periotome. After removing the tooth, careful degranulation of extraction socket will be performed using bone curettes and sterile saline. Evaluation of the bone, especially buccal bone, at the extraction site was performed gently using a periodontal probe.
i-PRF preparation:
The patient provided 9–10 mL of blood. After blood collection, we placed the blood in plain tubes, added no additional anti-coagulant, and immediately centrifuged each blood sample for 3 min at 800 rpm (60× g). As a result, three layers will be formed in the tube. The top layer is acellular plasma/platelet-poor plasma (PPP), the bottom layer is RBC concentrates, and the centre layer is orange coloured i-PRF which is carefully aspirated with sterile syringe and infused into collaplug.
Photobiomodulation:
Laser settings: Diode laser, 660–810 nm, 80–150 mW, continuous wave.
Dose: 4 J/cm² per point , ~40 s per point at 100 mW.
Application points: 3 sites per socket (buccal, lingual/palatal, occlusal over crest, apical to the socket).
Schedule: Immediately after suturing, then repeat after 24hrs, day 3 and day 7.
In the Comparator group, i-PRF and collaplug at the extraction site along with figure eight sutures will be placed and photobiomodulation with laser is done.
A postoperative pain assessment was performed 24 h, 3 days, and 7 days later and suture removal will be done at day 7.
The patient will be recalled after three months follow-up, where second CBCT examination will be taken
Ridge height, ridge width and bone density will be evaluated at baseline and after 3 months through CBCT.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Extraction of posterior teeth due to non-
restorable reasons and willing to go for
delayed implant placement.
2. Systemically healthy patients
3. No usage of antibiotics within 3 months before
the intervention
|
|
| ExclusionCriteria |
| Details |
1. Pregnant women
2. Smokers
3. Patients with allergies
4. Patients undergoing chemotherapy and radiotherapy
5. Patients with significant periapical pathology |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Ridge height, Ridge width |
Baseline to 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Bone density |
3 months |
| Pain rating scale |
24 hours, 3 days and 7 days |
| Wound healing index |
24 hours, 3 days and 7 days |
| Keratanized soft tissue thickness |
Baseline and 3 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
31/03/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study
is a Randomized, parallel group, active controlled trial comparing
the efficacy OF i-PRF and Collaplug with or without laser photobiomodulation in
alveolar socket Preservation for a period of 3 months in 40 patients ( intervention – i-PRF
and Collaplug with laser photobiomodulation in alveolar socket Preservation in 20
patients, comparator - i-PRF and Collaplug without
laser photobiomodulation in alveolar socket Preservation in 20
patients) conducted in Department of Periodontology, Sibar Institute of dental
Sciences. The primary outcome measures will be
comparing Ridge height, Ridge width from baseline to 3 months. The secondary
outcomes will be evaluating bone density at 3 months, pain rating scale and
wound healing index at 24 hours,3 days and 7 days, Keratanized soft tissue thickness
at baseline and 3 months. |