Effect of melatonin on bone formation when placed in the jumping gap in immediate dental implant placement - a case control study
Trial Snapshot
- Phase
- Phase 1
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- 1)CLINICAL ASSESSMENT by pink esthetic score to check gingival response and to assess the papilla height.
Study Overview
Brief Summary
This study is to assess the effect of melatonin on bone formation when placed in the jumping gap which is present after immediate dental implant placement. All the patients visiting the Department of oral and maxillofacial surgery of I.T.S. Dental College, Greater Noida and fulfilling the inclusion and exclusion criteria will be selected for the study to complete a sample size of 30 patients who will be randomly divided into two groups. This study will include patients between 25 and 65 years of age, having a hopeless tooth indicated for extraction (due to an unrestorable fracture or a carious lesion) requiring immediate dental implant placement. In 15 patient melatonin paste will be placed in the jumping gap after immediate dental implant placement followed by a customized gingival former to compare with the other 15 patients in the control group in which immediate dental implant placement will be done followed by customized gingival former. This study will assess the clinical and radiological outcomes of immediate dental implant placement with the use of a melatonin filled in the jumping gap to promote bone formation by evaluating the marginal bone level and bone density through IOPA at 0,3 and 6 months postoperatively and CBCT at 3 and 6 months postoperatively. Clinical assessment of the gingival response and the papilla height will be done with the pink esthetic score at 0,3 and 6 months postoperatively. All the patients will be prescribed with standard antibiotic and anti-inflammatory protocol along with necessary instructions after the treatment.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- None
Eligibility Criteria
- Ages
- 25.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patient having a hopeless tooth indicated for extraction (due to an unrestorable fracture or a carious lesion) requiring immediate dental implant placement.
- •The absence of any active infection/pus discharge and bone dehiscence on buccal wall of tooth socket.
- •Intact socket walls.
- •ASA Grade I and II.
- •Expected jumping gap of ≤ 2mm during implant simulation.
Exclusion Criteria
- •Aggressive periodontitis.
- •ASA Grade III and above.
- •External root resorption.
- •Patients who are at high risk of hormonal disturbances, mental disorders, seizures.
- •Pregnant women.
Outcomes
Primary Outcomes
1)CLINICAL ASSESSMENT by pink esthetic score to check gingival response and to assess the papilla height.
Time Frame: At baseline- radiographic assessment by IOPAR and CBCT | At 3 months - radiographic assessment by IOPAR and CBCT and clinical assessment by pink esthetic score | At 6 months- radiographic assessment by IOPAR and CBCT and clinical assessment by pink esthetic score
2)RADIOGRAPHIC ASSESSMENT by IOPA and CBCT to evaluate bone density and marginal bone level
Time Frame: At baseline- radiographic assessment by IOPAR and CBCT | At 3 months - radiographic assessment by IOPAR and CBCT and clinical assessment by pink esthetic score | At 6 months- radiographic assessment by IOPAR and CBCT and clinical assessment by pink esthetic score
Secondary Outcomes
- 1)To study the clinical and radiological changes occurring after placement of melatonin in jumping gap in immediately placed dental implants.(2)To study the clinical and radiological changes occurring when the jumping gap left unfilled in immediately placed dental implants.)
Investigators
Dr Anisha Grover
I.T.S. Dental college, hospital and research centre, greater noida