Treatment of bony problems With two types of bone growing agents.

Not yet recruiting

• Conditions: Other periodontal diseases,

• Registration Number: CTRI/2021/07/035226
• Lead Sponsor: N Hari Priya

Brief Summary

Periodontitis is an infectious disease of the supporting structures of the teeth

in which changes occurring within the alveolar bone are very crucial because

the destruction of the bone is responsible for mobility and tooth loss. The

resorption process of bone is usually interfered by various factors such as

severe gingival inflammation, changes within the bacterial plaque composition,

continuous or repeated trauma to the tooth by occlusal discrepancies and

systemic diseases.

One way of determining whether an inflammatory gingival lesion has

spread into the underlying periodontal structures is by radiographic evidence

of crestal alveolar bone loss and associated pocket formation. It is often

characterized by formation of intra-bony defects and the treatment of these

defects still remains a challenge to the clinician. Several regenerative

procedures have been described in the literature.



Graft material used for periodontal regeneration are categorized as autografts,

allografts, xenografts. Autografts and DFDBA have histologic evidence of pdl

regeneration in humans. Harvesting intraoral autogenous bone for pdl grafting is

often an unattractive option due to the limited quantity of bone available as well

as potential need for second surgical site. where as Decalcified freeze-dried

bone allograft (DFDBA) contains bone morphogenetic proteins (BMPs) that aid

in mesenchymal cell migration, attachment and osteogenesis have both

osteoinductive as well as osteoconductive activity and the ability to create and

maintain the space. DFDBA has been proposed as an effective regenerative

material for osseous defects.



Later on, research efforts shifted toward platelet concentrates because of the

acceleration of wound healing and stimulation of adjacent cells for the



restoration of the lost periodontium.

Platelet concentrates are way ahead of other biomaterials due to constant

release of growth factors over a time period, which are crucial for stimulation

of adjacent progenitor cells, leading to periodontal regeneration and tissue

healing.5 These platelet concentrates also have leucocytes, vitronectin,

fibronectin, bone morphogenetic proteins (BMPs), and cytokines that

contribute to different stages of the wound healing process.6 Initially, platelet-

rich plasma (PRP) was used alone or with bone graft in the treatment of intra-

bony defects. Although the results were reasonable, due to the risk of

antigenicity as a result of the addition of bovine anti-thrombin, leucocyte-

platelet-rich fibrin (L-PRF) was introduced, which does not require any kind of

anticoagulant.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2021-07-27
• Study Start: 2021-08-20

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• Presence of at least one tooth either on bilateral sides of the mouth with persistent probing depth (PD) ≥ 5mm.
• Radiographic evidence of intra-bony defects either on bilateral sides of the mouth with depth ≥ 3mm.

Exclusion Criteria

• Patients with uncontrolled systemic diseases.
• Patient who have underwent periodontal procedure 6 months prior.
• Pregnant or lactating women.
• Chronic smokers.
• Patient with grade III tooth mobility Patient with furcation involvement of grade II or more.
• Patient with trauma from occlusion.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the effectiveness of T- PRF in treating intra-bony defects based on clinical and radiographic parameters	CLINICAL PARAMETERS | All these will be evaluated at baseline 3 months and 6 months 9 months after the surgery | RADIOGRAPHICAL PARAMETERS | These parameters will be assessed at baseline 3months 6months | 9 months after surgery
To evaluate the effectiveness of DFDBA in treating intra-bony defects based on clinical and radiographic parameters	CLINICAL PARAMETERS | All these will be evaluated at baseline 3 months and 6 months 9 months after the surgery | RADIOGRAPHICAL PARAMETERS | These parameters will be assessed at baseline 3months 6months | 9 months after surgery
To compare the effectiveness of T-PRF versus DFDBA in	CLINICAL PARAMETERS | All these will be evaluated at baseline 3 months and 6 months 9 months after the surgery | RADIOGRAPHICAL PARAMETERS | These parameters will be assessed at baseline 3months 6months | 9 months after surgery
treating intra-bony defects based on clinical and radiographic parameters	CLINICAL PARAMETERS | All these will be evaluated at baseline 3 months and 6 months 9 months after the surgery | RADIOGRAPHICAL PARAMETERS | These parameters will be assessed at baseline 3months 6months | 9 months after surgery

Secondary Outcome Measures

Name	Time	Method
Amount of bone fill	Defect depth

Trial Locations

Locations (1)

Vishnu dental college; 🇮🇳 Godavari, ANDHRA PRADESH, India

Vishnu dental college

🇮🇳Godavari, ANDHRA PRADESH, India

N Hari priya

Principal investigator

8497907936

harichowdhary1996@gmail.com