"Comparing Two Methods of Dental Implant Placement in the Front of the Upper Jaw: A Study on Socket Shields vs. Traditional Immediate Implants"

Phase 3

Not yet recruiting

Conditions: preventive and screening intervention on volunteers with damaged maxillary anterior teeth

Registration Number: CTRI/2025/04/083947

Lead Sponsor: Sardar patel post graduate institute of dental and medical sciences

Brief Summary: The study shall be carried out on patients attending the Out Patient Department (OPD) of Oral and Maxillofacial Surgery, Sardar Patel Post Graduate Institute of Dental and Medical Sciences, with permission from Institutional Ethical Committee (IEC). A written informed consent will be obtained from each patient after explaining the nature and outcome of procedure and the possible consequences and complications. Patient will be selected irrespective of caste, creed, sex, religion or socio-economic status.Each patient will be randomly allocated to group I and group II using lottery method.All the cases will undergo thorough history taking and clinical examination. Radiographs will be taken (CBCT). Routine blood investigations and viral markers will be done.

Two groups will be made and patient will be randomly allocated to Group A (Socket shield technique) and Group B (conventional immediate implant placement).

Following consent the surgical field will be prepared and isolated and area will be anesthetized using 2% Xylocaine hydrochloride with epinephrine (1: 80,000). In Group A patients tooth extraction will be done by socket shield technique with the sequential use of burs. In the first step tooth crown will be sectioned at the cervical level followed by sectioning the tooth mesio-distally. This will split the roots labially and palatally followed by atraumatic removal of palatal portion of root. Thus the labial wall of root will be left intact and will be contoured in cresent shape. Now the site for implant placement will be prepared by sequential drilling, surrounded by tooth root on buccal side and bone on palatal side.

While in Group B patients tooth extraction will be done followed by immediate implant placement without leaving any portion of the tooth root in the extraction socket. Closure in both group A and group B patients will be done using 3-0 mersilk suture and patient will be evaluated for post operative pain and wound healing on 1st,3rd ,5th and 7th day ;for implant mobility, periimplantitis on 4th and 6th month, for implant stability at the time of implant placement and 6th month; for radiographic evaluation of buccal crestal bone height at pre-operative, immediate post operative ,4th month and 7th month.

Post operatively analgesics and antibiotics will be prescribed for 5 days. The patients will be advised to maintain proper oral hygiene.

Radiographs and photographs will be taken prior to extraction procedure and during follow ups at regular intervals.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 40

Inclusion Criteria

American Society of Anaesthesiologist Classification (ASA) I and II patient.
Patients under Sagital Root Position classification (SRP) class I and class II 2.
Patients with fractured maxillary anteriors without fractured cortical plates or any associated pathology 3.Patients age between 18-40 years 4.Good oral hygiene 5.Adequate bone volume for implant placement.

Exclusion Criteria

Not provided

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
primary outcome is to evaluate Mobility (Misch’s Clinical implant stability),Implant Primary and secondary stability (Osstell),Measurement of the amount of vertical and horizontal bone loss as seen on CBCT (Cone Beam Computed Tomography).	estimated time may range upto 7 months

Secondary Outcome Measures

Name	Time	Method
secondary outcome is to evaluate pain,wound healing,paillary index and periimplantitis	estimated time may range upto 7months

Trial Locations

Locations (1): Sardar patel Post Graduate Institute of Dental and Medical Sciences
🇮🇳
Lucknow, UTTAR PRADESH, India
Sardar patel Post Graduate Institute of Dental and Medical Sciences
🇮🇳Lucknow, UTTAR PRADESH, India
Dr Shreya Joshi
Principal investigator
8874894661
shreyajoshi910@gmail.com